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Site Name: USA - Massachusetts - Cambridge Posted Date: Apr 1 2024 GSK is seeking a highly motivated scientist to join the multidisciplinary Encoded Technologies (ET) team. As a member of the ET Affinity Selections and Biophysics Group, you will support small molecule drug discovery programs across GSK with specific accountability for applying biophysics expertise and techniques in hit discovery and validation, and further developing platform capabilities. Additionally, you will represent the group providing biophysics expertise to cross-functional project teams. The successful candidate will have hands-on experience with biophysics, chemical biology and/or protein biochemistry techniques (e.g., SPR, MST, DSF, affinity purification, alphaLISA, mass-spectrometry). Experience with targeted protein degradation, molecular glues, covalent probes, interrogation of cell lysates, membrane-bound proteins, and/or oligo therapeutics (e.g,. ASOs, AIMers) is a plus. This experience could be from an academic, biotechnology, or pharmaceutical industry setting. We seek a detail-oriented individual with a demonstrated ability to work in a team environment, including good communication and organizational skills, a strong desire to succeed, and the ability to deliver on time. GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent & technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better, & live longer. GSK is headquartered in London, UK with operations in the US; this opening is located at the Cambridge, MA, USA site. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... &bull; Deliver decision-making datasets in support of small molecule hit identification and validation programs &bull; C ontribute to advancing the platform technology via evaluation of new equipment and/or d evelopment and optimization of new methodologies &bull; Become a part of the multidisciplinary Encoded Technologies team while working independently &bull; Interact with other biophysicists, biologists and chemists across multiple GSK R&D sites &bull; Contribute to data analysis and have a chance to further develop analytical skills &bull; Contribute to publications, presentations, and collaborations that enhance the visibility of the team Why You? Basic Qualifications. &bull; BS with 5 years experience or MS degree in biophysics, biochemistry, bioengineering, biology, or similar discipline. Preferred Qualifications &bull; Self-motivated individual with good organizational skills and ability to effectively communicate experimental hypotheses, planning, and conclusions in a clear manner &bull; Ability to work flexibly within a team and in response to changes in strategic prioritization &bull; Experience in biophysical binding techniques, e.g., SPR (especially Carterra LSA), MST, nanoDSF, alphaLISA, trFRET, and/or other similar assays. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

public

Senior Scientist, Affinity Selections and Biophysics

Site Name: USA - Montana - Hamilton Posted Date: May 1 2024 As a Senior Compliance Specialist, you will support a multi-discipline team whose areas of responsibilities include: Leading investigations, CAPA management, Lean/Six Sigma program, project management within manufacturing and SAP, use of the SAP template with specific focus on the Production Execution (PEX) module of SAP. This role requires you to operate as an internal Manufacturing liaison to other manufacturing teams as well as the following site organizations: Quality, Manufacturing Science and Technology, Technical Services, Environmental Health and Safety, Process Safety Management and Business Process Management This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Promote a highly safety conscious culture and EHS focused workforce. </li><li>Support department supervisors to ensure that all operations throughout Manufacturing are in accordance to approved GSK process safety standards and OSHA requirements. </li><li>Perform all job responsibilities in compliance with applicable regulations, current operating procedures and industry practice. </li><li>Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times. </li><li>Acquire and maintain knowledge and understanding of SAP Production Execution (PEX) processes and understanding of manufacturing processes in order to manage the flow of materials appropriately. </li><li>Support the integration of new applications with SAP at the Hamilton site (i.e. Manufacturing Execution System (MES)) as well as support Global Business Owners (GBO) in the analysis of the Hamilton site role assignments. </li><li>Perform project management duties related to projects ranging from single department, small scope projects to multi-department, large scope projects.</li><li>Perform and monitor manufacturing processes using a highly automated approach based upon Emerson's Delta V platform. Troubleshoot process deviations resulting from automation communication issues. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's Degree in any Discipline and 5+ years of cGMP/healthcare/lab related experience OR </li><li>High School Diploma and 10+ years of cGMP/healthcare/lab related experience </li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Regulatory inspection experience</li><li>Knowledge of biological/vaccines manufacturing and its management, including relevant regulations governing the manufacture and supply of pharmaceutical products</li><li>Project management experience and knowledge of best practices associated and clear understanding of project management tools and approaches</li><li>Experience with SAP management demonstrating a quality mindset and knowledge of business processes in the pharmaceutical industry</li><li>Experience with Delta V automation</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Compliance Specialist

Site Name: USA - Montana - Hamilton Posted Date: May 1 2024 The Automation Engineer will assist the Automation Management in providing automation support to the Value Stream, serving as technical support on small and large projects, and driving alignment of site automation practices with global and industry engineering standards. The Automation Engineer participates in all the technical aspects of automated systems, low voltage systems, and Distributed/PLC controls. Responsibilities include coordination of suppliers, design management, lifecycle code management for automated systems, commissioning, and IQ/OQ for assigned systems. Automation is critical to the modern facility and manufacturing compliance; the Automation Engineer is required to coordinate efforts with other members of local and global teams. The Automation Engineer actively promotes the success of the Automation Engineering group through continual collaboration with the team. The Automation Engineer Champions the voice of the customer in decisions affecting Technical Services resource allocation and project prioritization. Ensure cGMP and ISA compliance of automated systems. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li>Assist in ensuring compliance and readiness for internal and external inspections and provide adequate support to inspected departments.</li><li>Support internal, external, and global regulatory agency audits as a subject matter expert.</li><li>Contribute to management of change activities for automation modifications, including management of design document updates, generation of engineering test protocols, and implementation/testing of solutions.</li><li>Generate automation-related deliverables and support automation work for implementation of configuration for small and large projects.</li><li>Actively supports production and facilities teams in investigations and troubleshooting, including participation in rotating on-call support.</li><li>Work with external suppliers to generate budgetary quotes for proposed automation systems, upgrades, and project deliverables.</li><li>Review and contribute to generation of plans for system installation and commissioning.</li><li>Performs triennial SOP reviews as required.</li><li>Performs gap analysis of local SOPs against Global Engineering Standards, GQPs, and GQMPs as required.</li><li>Support key global initiatives such as life cycle management, process data management, alarm management, and cyber security</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's Degree in Chemical, Electrical, Automation, or Computer Engineering</li><li>3+ years specialized automation engineering experience utilizing DeltaV or Rockwell PLCs</li></ul>Preferred Qualifications:<ul><li>Expertise in DeltaV or Rockwell PLC configuration</li><li>Experience in Aveva products for data management</li><li>Understanding of industry standards including ISA S88 Batch controls framework, IEC 61511 Functional Safety standards, and IEC 62443 ICS Cybersecurity standard</li><li>Previous training/continuing education classes around the topics of DeltaV and Rockwell/Allen Bradley products and software</li><li>Configuration and life cycle management experience with DeltaV Safety Instrumented Systems (SIS) logic</li><li>Expertise in DeltaV Live graphics configuration</li><li>Knowledge of virtualized system implementation and management using HyperV</li></ul>#LI-GSK #LI-Onsite Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Automation Engineer

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 16 2024 This is a significant role as part of the Global EHS Team for GSK. You will function as an Industrial Hygiene Subject Matter Expert (SME), helping to set standard for the central organization, and supporting sites, as needed. This focuses on the management of Industrial Hygiene and Ergonomics risks and the reduction of risk and improvement of controls. In role, you will support the management of Industrial Hygiene and Ergonomics within GSK, and primarily support North America manufacturing sites, requiring regional and international travel (from 10-20%) to site locations. This role offers an opportunity to influence Industrial Hygiene risk management within the Biopharma industry. You will have an extensive remit with significant responsibility and visibility across the region. To be successful, you will need the confidence, skill, and technical ability to develop effective working relationships globally and utilize this network to drive improvements in Industrial Hygiene and Ergonomics across GSK. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li> Leading Industrial Hygiene and Ergonomics across the region. </li><li> Ensuring an effective chemical, physical, biological, and ergonomic risk management strategy is in place at all sites in the region. </li><li> Providing in-depth technical support to the business in Industrial Hygiene, Ergonomics and other topics as identified. </li><li> Identifying key talent & building organizational capability within region. </li><li> Identifying and mitigating safety & business risks associated with Industrial Hygiene and Ergonomics. </li><li> Managing systems that support risk management initiatives across GSK Sites. </li><li> Working with Engineering and EHS colleagues to build solid business cases for significant capital investments and supporting significant capital investment projects with implementation of GSK standards, from concept to execution. </li><li> Support and collaborate with others on the development and implementation of relevant EHS Standards and technical guidance documents. </li><li> Working in close collaboration with above site Engineering and EHS colleagues to support their activity and leverage any synergies across the network, as well support site teams to cascade and develop improvements, good practice, and innovations. </li><li> Work with Site and regional Capital Engineering to provide input to site Facility Investment Plans to achieve risk reduction initiatives. </li><li> Coordination and management of existing global SME partners, while also building relationships with engineering consultancies to support Industrial Hygiene and Ergonomics programme. </li><li> Developing and presenting insightful data and information to leadership team regarding status and performance against Industrial Hygiene and Ergonomics objectives, and gain support for initiatives. </li><li>Provide proactive and reactive technical support and oversight to audits and incident investigations.</li></ul>Why you? Basic Qualifications: <ul><li>Bachelor's degree level qualification in Industrial Hygiene, EHS, Physical Science or Engineering</li><li>Industry certification (e.g., CIH, CMFOH or locally recognized IH certification)</li><li>8+ years' experience performing IH and Ergonomics risk management activities.</li><li>4+ years Industry experience in a related sector, such as Pharmaceutical, BioPharma, Consumer Health manufacturing or similar</li><li>2+ years' experience and proven technical and leadership skills managing Industrial Hygiene program</li></ul> Preferred Qualifications: <ul><li>Master's degree or equivalent in Industrial Hygiene, EHS, Physical Science or Engineering</li><li>Six Sigma and Lean Manufacturing experience</li><li>Knowledge in the use of the Cority IH Database and Bayesian statistical analysis of data</li><li>Experience in developing containment solutions to manage chemical exposures.</li><li>Regional leadership experience</li><li>S trong relationship building and networking, to engage effectively with a range of stakeholders including EHS and Engineering Regional leads, site personnel, senior management and more </li><li> Strong report writing and presentation skills, and the ability to influence others, deliver training and to develop site employees as you build capability across the network. </li><li> Critical thinking and analytical skills to identify opportunities for simplification and improvement and apply a strategic mindset to deliver work across the network efficiently and effectively. </li><li> Ability to work well in a high-performance team and deliver a variety of work for the Global EHS Team while supporting our manufacturing sites. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Regional Industrial Hygiene and Ergonomics Manager

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 1 2024 Thank you for your interest in our Bio Pharm Manufacturing Associate II (Evergreen) position. Applicants for this role will not be receiving immediate feedback regarding their applications. If you are looking for an immediate opportunity, please take a look at the GSK careers page for opportunities that would align with your skill-set. I have included the link here for your convenience: Careers | GSK US . We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together. As a Biopharm Manufacturing Associate II, you will perform production operations including fermentation or cell culture operations, preparation of solutions, chromatographic separation, filtration and concentration operations, autoclave and parts washing of process assemblies, and area cleaning/upkeep. Will be responsible for completing daily manufacturing tasks, and increasing competency in different production areas over time. Will participate in safety and compliance initiatives, as well as investigations. Will engage in the GSK Production System to continuously improve safety, quality, and schedule/cost performance. The purpose of this role is to be a part of a dynamic, multi-tiered operations team that brings life changing and life saving medicine to patients around the world. They will demonstrate GSK Values (Patient Focus, Transparency, Respect, & Integrity) and Expectations (Courage, Accountability, Development, & Teamwork) on a daily basis by engaging positively with team members and production support groups. Under the direction of senior personnel, the biopharmaceutical manufacturing associate II performs a variety of largescale production operations, interacting with automated equipment and monitoring/processing data. Will be responsible for completing daily manufacturing tasks, and increasing competency in different production areas over time. They will participate in safety and compliance initiatives, investigations, and help solve technical and organizational problems while working with different teams of experts. Will work within these teams to continuously improve safety, quality, and schedule/cost performance. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li>Demonstrate GSK Values - Patient Focus, Transparency, Respect, and Integrity - in every interaction, in every work task, and with every responsibility of the job role. Live GSK's Expectations of Courage, Accountability, Development, and Teamwork to achieve high performing behaviors in the workplace.</li><li>With good documentation and data integrity practices, safely and compliantly completes and documents daily manufacturing tasks per standard operating procedures, batch document instructions, and logbooks</li><li>Proactively works with senior staff to achieve competency in production operations</li><li>Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution. Primarily these activities are within the production suite, but sometimes require out of suite or off-site work (i.e. FAT support)</li><li>Monitors equipment and critical process parameters, and escalates any issues or abnormalities and participating the resulting troubleshooting activities</li><li>Strives to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc)</li><li>By learning the production schedule and assessing it daily, proactively ensures all processing equipment and necessary materials are adequate and available to set the team up for success</li><li>Transparently participates in investigations that are the result of safety or compliance issues.</li></ul>Why you? Basic qualifications:<ul><li> BS/BA degree, with cGMP manufacturing experience </li><li> OR an Associate's degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience </li><li> OR High School degree, 1+ years of cGMP manufacturing experience. </li></ul> Preferred Qualifications:<ul><li> Demonstrated level of high performance </li><li> Strong verbal and written skills </li><li> The ability to work well in a team environment </li><li> Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Biopharm Manufacturing Associate II

Site Name: Collegeville TSA Posted Date: Apr 1 2024 Are you looking to enhance your immunoassay development techniques by working for a global pharmaceutical company that allows you to leverage best in class systems and technologies? If so, this Immunoassay Investigator role is the ideal opportunity for you. We are looking for a highly motivated, flexible and experienced scientist to join a team within the Biomarker Platforms department based in Collegeville, PA. As an Immunoassay Associate Director, you will be responsible for the development, validation and sample analysis of PK assays for use in support of clinical programs in alignment with therapy area partners. Data from this group is a key component to understanding molecules in the GSK pipeline; and serves to make early and informed decisions for asset progression within the organization. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li>Responsible for developing bespoke assays to support clinical studies; delivery of robust, high quality data packages and will demonstrate the ability to critique work to enable lead modalities to be smoothly progressed through clinical drug development.</li><li>Independently providing sample analysis support for clinical studies by delivering high quality data packages working in a GLP/GCP compliant laboratory setting.</li><li>Deliver, interpret and communicate complex scientific data to project/program teams in a timely manner by performing data analysis, record keeping and reporting of results to agreed timelines.</li><li>Works and communicates effectively with the group and speaks up when necessary.</li><li>Contribute to departmental strategy and capital investment discussions.</li><li>Handling of human biological samples and performing experimental work in accordance with HBSM, safety and data integrity guidelines. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>PhD in Biology, Biochemistry, Immunology or related discipline with ≥5 years or BS/MS with ≥10 years of experience in a regulated pharmaceutical or biotechnology environment with a thorough understanding of the drug development process.</li><li>Three or more years of hands-on experience and theoretical understanding of clinical immunoassay development, validation and study support for either PK or biomarker (ELISA/MSD/Gyros).</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Proven ability to provide translational expertise on programs/project teams for clinical studies with a wide variety of techniques and technologies. </li><li>Strong publication/presentation history</li><li>Biomarker experience is a plus</li><li>Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.</li><li>Attention to detail and good communication and documentation skills will be expected. </li><li>Highly motivated team player with a proactive attitude, excellent organizational skills and a demonstrated ability to interact effectively within a multi-disciplinary team are essential.</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Immunoassay Associate Director, LBA

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 1 2024 We are looking for a highly motivated, flexible and experienced scientist to join the Cellular Biomarkers Flow Cytometry team within Biomarker & Bioanalytical Platforms in the Precision Medicine department located in Upper Providence, US. The team is responsible for the development and validation of complex multi-parameter flow cytometry panels and subsequent application of these panels to clinical trial sample analysis. The deep immunophenotyping data generated by these biomarker panels helps us to evaluate disease heterogeneity, drug-target engagement, drug mechanism of action and patient responses. The successful candidate will have a deep understanding of immunology and will act as a flow cytometry technical expert, supporting high parameter deep immunophenotyping of immune cell subsets as well as receptor occupancy endpoints. This is a lab-based role and will include all aspects of flow cytometry method development and optimization, validation and sample analysis for clinical studies across the entire GSK portfolio. This role will be responsible for completion of all aspects of assay workflow including reagent selection, sample preparation, sample acquisition, data analysis, interpretation and presentation. In addition, this role will ensure all work is conducted in compliance with GCP regulations including adherence to the appropriate SOPs. In this role you will <ul><li>Generate high quality data to support clinical studies by spectral flow cytometry (Cytek Aurora)</li><li>Conduct and oversee all aspects of method development, troubleshooting, validation and sample analysis for clinical studies</li><li>Handle human biological samples and perform experimental work in accordance with GCP regulations, safety assessments and data integrity guidelines</li><li>Be responsible for delivery of robust, high-quality data packages</li><li>Deliver, interpret and communicate complex scientific data to project/program teams within agreed timelines</li><li>Contribute to biomarker strategy and capital equipment discussions</li><li>Help lead efforts to investigate novel cytometry and data analysis platforms and embed them within the organization</li><li>Manage multiple projects concurrently</li><li>Function well in a team and possess a good balance of creative and analytical skills</li><li>Be willing to develop and train others as required</li></ul>Why you? Basic Qualifications: <ul><li>Bachelors degree and six or more years' relevant experience or PhD with two or more years' experience</li><li>Two or more years' experience with immunological enabling phenotyping of multiple cell lineages</li><li>Two or more years' experience with flow cytometry and in design and execution of 16+ colour flow cytometry panels</li><li>Two or more years' of laboratory experience and expertise working with a variety of sample types including whole blood, PBMC, cell lines and single-cell suspensions from tissues</li></ul> Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: <ul><li>A good understanding of the drug development process</li><li>Experience in design and execution of 22+ colour flow cytometry panels</li><li>In-depth knowledge of various immune subsets</li><li>In-depth knowledge of receptor occupancy assays</li><li>Hands on practical experience with the Cytek Aurora</li><li>Strong laboratory experience and understanding of clinical and non-clinical flow cytometry biomarker assay development, validation and implementation</li><li>Hands on experience with high-dimensional data analysis ( e.g. tSNE, UMAP, CITRUS, FlowSOM)</li><li>Experience of technology transfer of flow cytometry assays to Contract Research Organizations</li><li>Experience of writing SOPs and other regulated documents</li><li>Willingness to work with human samples infected with blood borne pathogens including HIV and HBV, etc.</li><li>Considerable experience in the use of flow cytometry analysis software (OMIQ preferred)</li><li>Ability to maintain a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence even when flexing between multiple projects</li><li>Attention to detail, good communication and documentation skills</li><li>Ability to work independently to tight deadlines with a proactive attitude</li><li>Be a highly motivated team player with the ability to interact effectively within a multi-disciplinary team</li><li>Ability to problem solve and troubleshoot</li><li>Good judgment and decision making, especially for prioritizing multiple requests</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Principal Scientist, Flow Cytometry

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 2 2024 Are you an ambitious Oncology Clinical Development professional looking to advance your career in the pharmaceutical industry? Take a look at this position and engage with us to explore broader opportunities in GSK's Oncology Clinical Development division today. The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents. Key Responsibilities<ul><li>Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials</li><li>Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe. </li><li>Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making </li><li>Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. </li><li>Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and medical data review.</li><li>Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.</li><li>Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.</li><li>Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.</li><li>Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.</li><li>Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature. </li><li>Serve as a core member of the Clinical Matrix Team for one or more assets in development.</li><li>Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.</li><li>Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.</li></ul> *LI-GSK Basic Qualifications Include: <ul><li>Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology or internal medicine (with hematology or oncology experience)</li><li>Academic and/or clinical research publications or clinical medical practice in the field of oncology.</li><li>Clinical drug development process experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.</li><li>Regulatory experience to support registration and GCP principle</li></ul>Preferred Qualifications include:<ul><li>Strong experience in pharmaceutical industry or related oncology clinical practice experience</li><li>Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Expressions of Interest - Oncology Clinical Development Physicians

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 30 2024 This role will be located in Collegeville, PA and will require the new employee to work 5 days a week onsite to support our employees working in the Laboratory. We are looking for a highly motivated, agile and experienced immunologist to lead our Cellular Biomarkers Flow Cytometry team within the Biomarker and Bioanalytical Platforms department. Our group is responsible for developing and validating complex multi-parameter biomarker assays for use in clinical studies. We generate deep immunophenotyping data to evaluate disease heterogeneity, drug-target engagement, drug mechanism of action and patient responses. The successful Director, Flow Cytometry US Group Leader will have a deep understanding of immunology and will serve both as a group leader and as a technical expert. Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Provide scientific leadership and guide the development and validation of various high parameter spectral (Cytek Aurora) flow cytometry assays including deep immunophenotyping of immune cell subsets and receptor occupancy endpoints.</li><li>Oversee all aspects of method development, troubleshooting, validation and sample analysis for those clinical studies withflow cytometry endpoints.</li><li>Manage, develop and train a team of PhD and non-PhD scientists</li><li>Provide biomarker/translational expertise on multiple clinical programs/projects including influencing biomarker strategy</li><li>Be responsible for delivery of robust, high-quality data packages</li><li>Ensure all work is conducted in compliance with GCLP regulations and follow the appropriate SOPs.</li><li>Guide your team in successful interactions with CRO partners to assist in the delivery of high-quality clinical flow cytometry endpoints</li><li>Deliver, interpret and communicate complex scientific data to project/program teams within agreed timelines</li><li>Ability to handle multiple projects concurrently</li><li>Able to function well in a team and possess a good balance of creative and analytical skills</li><li>Contribute to capital equipment discussion</li><li>Lead efforts to investigate novel flow cytometry data analysis platforms and embed them within the organization</li></ul>Why You? Minimum Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>PhD in immunology, cell biology or similar field</li><li>6 or more years post-PhD work experience in immunology, cell biology, or biomedical science</li><li>Experience in biomarker/translational work on multiple clinical programs/projects</li><li>People leadership experience of a large team ( 10 to 15 direct reports) and ability to lead a team of PhD and non-PhD level scientists</li><li>Experience in immunology covering phenotyping of multiple lineages of cells</li><li>Laboratory experience working with clinical and non-clinical flow cytometry biomarker assay development, validation, and implementation</li><li>Experience in high dimension flow cytometry and in the design and execution 16+ color flow cytometry panels</li><li>Experience in the use of flow cytometry analysis software like OMIQ</li><li>Experience working with a variety of sample types including whole blood, PBMC, cell lines and single-cell suspension from tissue samples</li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Excellent collaboration and interpersonal skills to influence biomarker testing strategies and communicate efficiently with colleagues from all phases of clinical drug development</li><li>Ability to maintain a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence</li><li>Ability to problem solve and troubleshoot</li><li>Demonstrated judgment and decision making, especially for prioritizing multiple requests</li><li>Experience in the development and validation of novel flow cytometry assays to support clinical measurements and their translation to a companion diagnostic (CDx) when applicable.</li><li>Experience of working with external vendors for the transfer of assays to support clinical trial sample analysis and development of CDx (where appropriate)</li><li>Experience to design and execute 25+ color flow cytometry panels</li><li>Hands on experience with the Cytek Aurora</li><li>Hands on experience with OMIQ</li><li>Proactively demonstrate the ability to work to tight deadlines</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Flow Cytometry US Group Leader

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for the delivery of automation and controls systems at an important sterile drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Automation Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process.* As an Automation Manager, you will be responsible for the team accountable for successful investment related to automation, controls, and digital, data & analytics (DDA) implementation. Team responsibilities include the ideation, specification, design, delivery, construction, start-up, and qualification of instrumentation, controls, and execution digital systems for all aspects of drug product manufacturing including formulation, filling, assembly, packaging, and support infrastructure (utilities, labs, warehousing). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... <ul><li>Direct operational and technical stewardship of delivery of digital assets and solutions at all network levels, including Level 3 - Execution systems (e.g. MES, LES), Level 2 - Control systems (e.g. DCS, BAS), and Level 1 (e.g. IoT).</li><li>Direct engineering and technical efforts in the design, specification, procurement, and deployment of automation and digital assets & applications. Direct automation and coding efforts in the design, implementation, and operational support of automated and digital solutions across site.</li><li>Assure that all digital operations are compliant with GSK guidelines/standards, safety regulations, and quality requirements, especially as they pertain to cyber security and data integrity.</li><li>Assure business continuity in all aspects of automated solutions and digital operations, including but not limited to: network and system security against cyber threats, data integrity and availability, critical spares, asset supportability, and license to operate it pertains to EHS and Quality Compliance.</li><li>Create, own, and deliver the investment according to the site's digital strategy:<ul><li>Delivers measurable value to the business and aligns with broader objectives and strategy.</li><li>Advances the site's digital posture.</li><li>Better aligns the capability and composition of the site's workforce with its digital trajectory.</li><li>Drive maturity in the space of digital solutions and data-based insights.</li><li>Drive value to the business through innovation and transformational technologies such as AR/VR, robotics, biometrics, and ML/AI.</li><li>Own and manage project relationships with PSC Tech and other DDA stakeholders.</li></ul></li><li>Guide / mentor / coach team as they deliver scope - support their generation of possible solutions and the selection and buy-in of the final solution. Follow-up to ensure the solution is implemented appropriately and satisfies the customer's requirements.</li><li>Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> BS/BA in engineering, computer science, or equivalent technical discipline </li><li>8+ years of automation or digital operations experience with at least 5 years in a manufacturing or life sciences environment. Prior experience directly managing a technical staff and remit related to automation or digital operations.</li><li> Experience working in a regulated GMP environment. </li><li> Pharmaceutical/biotechnology industry experience. </li><li> Prior project engineering and/or technical management experience. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> MBA with Digital Specialization, master's in engineering, Masters in CS </li><li> Professional Engineering (PE) license or Chartered Engineering status preferred. </li><li> Demonstrated ability to interact well with peers and across all levels of the organization. </li><li>Demonstrated effective management of significant capital and ownership of systems subject to audits from oversight groups and regulatory bodies.</li><li>Demonstrated capability of leading large matrix organizations with excellent communication, influencing, and coaching abilities at all levels within the organization</li><li>Leadership skills that enable the introduction of new ways of working and accelerated change management</li><li>Proven capability to lead and motivate teams (line & matrix; and multi-disciplinary & cross-functional) to deliver business solutions and benefits.</li><li>Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.</li><li>Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.</li><li>Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li> Demonstrated ability to lead and inspire technical groups. </li><li> Proficient with application and administration of manufacturing control systems, building automation systems, servers, industrial communications/LAN, and data historians. </li></ul>#LI-GSK #Globalsupplychain #MariettaGSC #Vaccinessupplychain Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Automation Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for the validation of equipment and systems at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Validation Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*. As a Validation Manager, you will be responsible for leading the team responsible for validation of equipment and facilities for the manufacture of biological drug substance and sterile drug product. Validation team responsibilities include the strategy, planning, execution, completion, and maintenance protocols to ensure all processes used in manufacturing and testing remain in a validated state. Fluency in (bio)pharmaceutical processes, facilities, operations, validation methods, and GSK standards in project management, validation, quality, and EHS are essential. Individual management of individual protocols also foreseen. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li>Lead a team of validation engineers who are individual experts in area specific bioprocess equipment and facility and control system validation. The quality of the validation program has a direct impact on compliance to cGMP's and the ability of the supply chain to gain regulatory approval to manufacture.</li><li>Test and successfully introduce new equipment and processes into the facility - including drug substance unit operations such as buffer preparation, UFDF, mixing, and homogenization and drug product unit operations such as formulation, filling, assembly, and packaging. </li><li>Fluent in quality by design and validation industry standards for equipment and facilities and also innovations in validation execution. Familiar with statutory guidance and GSK standards for above. </li><li>Define and optimize the overall validation strategies, policies, and programs. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations.</li><li>Manage the development and execution of validation protocols for all facility services, utilities, equipment, cleaning, maintenance, and systems including computer systems.</li><li>Manage the development, implementation, and maintenance of validation documentation. </li><li>Interface with regulatory inspectors on all validation issues, and present and defend the validation program in regulatory audits.</li><li>Provide validation technical assistance to other GSK organizations when needed. Participate in cross organizational validation discussion and development efforts.</li><li>Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements.</li><li>Guide / mentor / coach team - support their generation of possible solutions and the selection and buy-in of the final solution. Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.</li><li>Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's degree in engineering or equivalent technical discipline; Mechanical or Chemical Engineering </li><li>10+ years of pharmaceutical industry validation experience</li><li>Experience leading technical teams.</li><li>Experience with regulatory compliance.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li> MBA, master's in engineering, and/or Professional Engineer </li><li>10+ years of prior project and/or operational validation experience in the pharmaceutical industry is preferred. </li><li>Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities.</li><li>Familiar with cGMPs, PDA, FDA regulations.</li><li>Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities.</li><li>Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.</li><li>Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.</li><li>Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li>Sense of Urgency / Decision making.</li><li>Strong interpersonal skills.</li><li>Must be able to work within a multi-disciplinary team environment.</li><li>Must be able to generate options to resolve problems, prioritize solutions and implement decisions.</li><li>Must be competent in handling simultaneously occurring tasks and have excellent written and oral communication skills.</li></ul>#LI-GSK #Supplychaincritical #MariettaGSC #MariettaVaccines Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Validation Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 The Quality Systems Manager is responsible for developing and administrating support systems for the production of biologics at the Marietta facility. The Quality Systems Manger is accountable for ensuring that all cGMP systems are compliant with GSK internal procedures, policies, standards, and applicable government cGMP regulations. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Lead the QA Systems team and ensure that all team members display a quality mindset in their performance and behaviors. </li><li>Identify the strengths of each team member and ensure that each team member is a good fit for their role. </li><li>Accountable for development of the QA systems team.</li><li>Accountable for the management of all cGMP quality systems (includes deviations, CAPAs, change control, QMS, and others). </li><li>Accountable for the management of Documentation systems (including procedures management, equipment logbooks, archival, and others).</li><li>Accountable for developing and maintaining visual process maps that describe each cGMP system, the interaction between cGMP systems, and the accountabilities and responsibilities of roles in each cGMP system. </li><li>Accountable for integrating cGMP system maps with the SAP business process diagrams developed and maintained by business process owners (in Operations, Quality Unit, and LTS) so that data movement, document flow, logical process flow, and workflow can be shared and communicated comprehensively (or separately, as needed) and clearly. </li><li>Accountable for continuously driving improvement in business processes and business systems to improve compliance and productivity over time.</li><li>Accountable for post-marketing surveillance (complaints and PQR systems and processes).</li><li>Accountable for maintaining the relationships between local cGMP system owners and cGMP system owners at other sites and in global functions in order to share good practices, learning, and system issues and improvements.</li><li>Accountable for leading or managing quality systems improvement and simplification projects and site initiatives as applicable.</li><li>Accountable for routinely, frequently, and accurately measuring and communicating the suitability (fit for use), performance, compliance, and effectiveness of cGMP systems.</li><li>Maintain all systems in a state of continuous readiness for regulatory inspections.</li><li>Accountable for the Quality escalation and Quality alert processes. Act as the site single point of contact to Regional QA for escalation events and quality alerts. Ensure that each escalation event is closed and status is reported back to Marietta.</li><li>Responsible for compliance with the GSK safety procedures and all applicable EHS regulations, standard operating procedures, and industry practices.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> BS or BA in a Science discipline. </li><li> Minimum of 5 years' prior experience supervising quality assurance (Quality Systems, compliance, product release) within clinical or commercial organization. Supervision to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and discipling others. </li><li> Minimum of 3 years' prior experience with licensed biopharmaceutical or biological products </li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> Master's degree in science or business discipline. </li><li>Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.</li><li>In-depth experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department. </li><li>Strong technical understanding of industry and science practices related to the business</li><li>Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships</li><li>Formal training in quality systems design or administration by a recognized industry organization such as ASQ.</li><li>Lean / six sigma training (green belt, black belt, master black belt certification).</li></ul> #LI-GSK #GSKMarietta #MariettaGSC Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Quality Systems Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for engineering at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Process Engineering Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*. As a Process Engineering Manager, you will be responsible for leading the team responsible for engineering of equipment and facilities for the manufacture of biological drug substance and sterile drug product. Engineering team responsibilities include the design, delivery, construction, start-up, and qualification of process equipment and areas including drug substance purification, drug product formulation, filling, assembly, and packaging. Responsibilities are by first intent for projects executed within the US. Fluency in (bio)pharmaceutical processes, facilities, operations, engineering methods, and GSK standards in project management, operations, quality, and EHS are essential. Individual management of individual processes and equipment also foreseen. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li> Lead a team of process engineers who are individual experts in area specific bioprocess equipment and facility design / operation. </li><li> Deliver new equipment and processes into the facility - including drug substance unit operations such as buffer preparation, UFDF, mixing, and homogenization and drug product unit operations such as formulation, filling, assembly, and packaging. </li><li> Support the construction, commissioning, qualification, and 24/7 manufacture of vaccines and medicines critical to patient quality of life and support critical revenues for the company. On-call support for manufacturing troubleshooting and planned upgrades is a team necessity. </li><li> Fluent in biopharma industry standards for equipment and facility design for cleanability and bioburden control. Expert in CIP/SIP design and operational principles. Familiar with statutory guidance for above (ASME BPE, ISPE). Fluent in sterile fill industry standards for equipment and facility design. </li><li> Manage efforts and resources required by project teams to meet technical, budget, and schedule goals. Expert in multi-tasking, scheduling, budgeting, and project management. Familiarity with equipment supplier, preferred subcontractor, and consultant engineering markets to support site projects as needed with competitive cost and service. </li><li> Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements. </li><li> Guide / mentor / coach team as they deliver equipment and facility packages - support their generation of possible solutions and the selection and buy-in of the final solution. Follow-up to ensure the solution is implemented appropriately and satisfies the customer's requirements. </li><li> Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering. </li><li> Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's degree in engineering or equivalent technical discipline.</li><li>10+ years in Engineering and Plant Operations</li><li>Experience with biopharmaceutical equipment and manufacturing processes.</li><li>Experience managing capital and systems subject to audits from regulatory bodies.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Master's degree in engineering</li><li> 10+ years of prior project and/or process engineering experience in the pharmaceutical industry is preferred. </li><li> Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities. </li><li> Demonstrated ability to manage projects >$10m to completion on time and within budget (minimum), preference for >$50m. </li><li> Familiar with cGMPs, GEPs. </li><li> Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities. </li><li> Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines. </li><li> Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams. </li><li> Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li> Sense of Urgency / Decision making. </li><li> Strong interpersonal skills. </li><li> Must be able to work within a multi-disciplinary team environment. </li><li> Must be able to generate options to resolve problems, prioritize solutions and implement decisions. </li><li> Must be competent in handling simultaneously occurring tasks and have excellent written and oral communication skills. </li><li> Project Management Professional Program Certification or Professional Engineer license </li></ul>#LI-GSK #Supplychaincritical #MariettaGSC #MariettaVaccines Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Process Engineering Manager

Site Name: USA - Pennsylvania - Marietta Posted Date: May 1 2024 Are you interested in leading a team responsible for the delivery of utility systems and infrastructure at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative sustainable technology and building a team to be successful? If so, this Facilities Engineering Manager role could be an excellent opportunity for you to explore. *The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*. As Facilities Engineering Manager, you will lead the team responsible for engineering of the utilities, facility, statutory compliance, and infrastructure for the manufacture of biological drug substance and sterile drug product. Facility engineering team responsibilities include the design, delivery, construction, start-up, and qualification of mechanical, electrical, and utility systems of biopharmaceutical manufacturing facilities including drug substance purification, drug product formulation, filling, assembly, and packaging. The team is also responsible for engineering project compliance to the GSK statutory framework of engineering and EHS standards and specifications and the project's auditable compliance framework. Responsibilities are by first intent for projects executed within the US. Fluency in (bio)pharmaceutical facilities, operations, engineering methods, and GSK standards in project management, operations, quality, and EHS are essential. Individual management of specific services or equipment (utilities, electrical, HVAC) also foreseen. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li> Lead a team of facility engineers who are individual experts in area specific equipment and infrastructure design / operation. Team responsibility also includes engineering compliance. </li><li> Deliver new utility and infrastructure equipment and processes into the facility - including utilities such as WFI, clean steam, compressed air, plant steam, cooling water, hot water, HVAC, and electrical. </li><li> Support the construction, commissioning, qualification, and 24/7 operation of infrastructure supporting manufacture of vaccines and medicines critical to patient quality of life and support critical revenues for the company. On-call support for troubleshooting and planned upgrades is a team necessity. </li><li> Fluent in biopharma industry standards for clean utility equipment and facility design. Familiar with statutory guidance for above (ASME BPE, ISPE). </li><li> Manage efforts and resources required by project teams to meet technical, budget, and schedule goals. Expert in multi-tasking, scheduling, budgeting, and project management. Familiarity with equipment supplier, preferred subcontractor, and consultant engineering markets to support site projects as needed with competitive cost and service. </li><li> Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements. </li><li> Guide / mentor / coach team as they deliver scope - support their generation of possible solutions and the selection and buy-in of the final solution. Follow-up to ensure the solution is implemented appropriately and satisfies the customer's requirements. </li><li> Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering. </li><li> Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. </li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's in engineering or equivalent technical discipline. </li><li> 10+ years of prior project and/or process engineering experience in the pharmaceutical industry </li><li>Familiarity with biopharma mechanical, electrical, architectural, instrumentation, and utility equipment.</li><li>Experience with architectural, HVAC, purified water systems, boilers, chillers, towers, electrical, and other utility and infrastructure.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li> MBA, master's in engineering, and/or Professional Engineer </li><li> Prior project experience in the design, construction, start-up and operation of pharmaceutical facilities. </li><li> Demonstrated ability to manage projects >$10m to completion on time and within budget (minimum), preference for >$50m. </li><li> Familiar with cGMPs, GEPs. </li><li> Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities. </li><li> Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines. </li><li> Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams. </li><li> Must be comfortable and thrive in ambiguity and think strategically to solve complex problems. </li><li>Demonstrated capability of leading large matrix organizations</li><li>Excellent communication, influencing, and coaching abilities.</li><li>Leadership skills that include change management</li><li>Demonstrate initiative, creative, and analytical problem-solving skills.</li></ul>#LI-GSK #Supplychaincritical #MariettaGSC #MariettaVaccines Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Facilities Engineering Manager

Site Name: USA - Maryland - Rockville Posted Date: Apr 1 2024 GSK is currently looking for an Associate Director-Production to join our team in Rockville, MD. In this role, you'll manage production operations in Biopharmaceutical Manufacturing Facilities. Key Responsibilities <ul><li>The Manager of Production is responsible for the production biotechnology platforms operating on a 24hour/7day basis. The job duties require a high level of technical knowledge combined with a sense of urgency and responsibility to meet delivery schedules.</li><li>Responsible for the preparation of bulk biopharmaceutical drug substance to meet all quality standards for GSK, FDA and any other regulatory agency which applies.</li><li>Responsible for assuring full compliance against all appropriate manufacturing regulations such as local policy and procedures, GSK QMS and CFR/cGMP.</li><li>Responsible for all operations, to ensure personnel, product and equipment safety. Maintain compliant operations against all required GSK EHS/OSHA standards and all applicable environmental regulations (local, state, and federal).</li><li>Partner with the NPI lead for successful implementation of new products and processes into the facility production equipment and schedules.</li><li>Accountable for the accurate preparation and execution of manufacturing procedures and batch records.</li><li>Establish production standards and manpower requirements to meet delivery schedules.</li><li>Direct the evaluation and implementation of Continuous Improvement and OE methods and tools to improve the overall efficiencies of production operations and reduce costs.</li><li>Accountable for the personnel development and performance management planning for all direct and indirect reports.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li> BS/BA Degree </li><li> 7+ years of production in biopharm/biotech or similar technology-based industry </li><li> Minimum of 3 years production management experience. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li> 5 years of large scale cell culture or fermentation based processing preferred as well. </li><li>Strong quality/compliance orientation and track record. </li><li>Excellent interpersonal and leadership skills. </li><li>Strong influence and relationship building skills with an emphasis on teamwork</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Associate Director, Production

Site Name: USA - Massachusetts - Cambridge, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence Posted Date: Mar 4 2024 The Senior Director, Transactions is a senior role in the R&D organization at GSK, where the role holder supports global business development and licensing initiatives and has a direct impact on the success of GSK's strategy and portfolio. The Transactions team sits within global business development and is responsible for leading the negotiation and execution of license agreements, acquisitions, complex collaborations and strategic alliances, across multiple core therapeutic areas (oncology, respiratory & immunology).By effectively synthesizing and communicating the merits of potential investment opportunities and negotiating them with external parties, the role holder will enable enterprise decision-making related to business development opportunities. A strong understanding of the deal-making process in the industry is required as the role holder will be responsible for leading transactions-related activities. The successful candidate will also have a strong transactional background in biopharma, proven project and people leadership, business and strategic acumen and excellent communication skills. Furthermore, the candidate will have an ability to engage and collaborate across organizational boundaries with an entrepreneurial attitude. Key Responsibilities : This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Serving as the internal lead in both preparation and presentation of transactional aspects of each business case for senior management with support from functions across the business, including legal and corporate development.</li><li>Co-lead, with the senior Search & Evaluation team, the development of business case assessments and recommendations of external opportunities, including deal proposals, valuation, deal status, and key issues of the transaction to GSK governance bodies for endorsement.</li><li>Oversees and leads the drafting of non-binding term sheets and definitive agreements and serves as a key point of contact with the external partner throughout the deal process from submission of NBTS to signature. </li><li>Works with key stakeholders and cross-functional teams to ensure effective communication, efficient decision-making, to support completion of transactions in a timely manner.</li><li>As appropriate participate in Joint Steering Committees of major Strategic collaborations with Alliance Management colleagues to provide effective decisions and drive a successful external portfolio of projects.</li><li>Establishes and maintains a broad network of internal and external stakeholders and maintains a high level of external visibility. </li><li>Accumulates expertise in industry trends in deal-making and deal structures.</li><li>Coaches other Transaction team members as applicable.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Advanced degree in science, law or business (e.g., MS, LLM, MBA, PhD, JD, MD)</li><li>10 + years of experience in life sciences industry and 6+ years of relevant biopharma business development transactions experience (licensing, collaborations and/or M&A) in leading multiple closed deals (deal sheet required). </li><li>Experience integrating scientific knowledge into business model and analyzing sales forecasts, P&Ls, risk analyses, and company valuations.</li><li> Experience building successful internal/external global partnership and collaboration relationships .</li><li>Expertise in reviewing and editing contracts and providing direction to Legal team members in term sheets and contracts. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Strong analytical, communication, and leadership skills, with ability to synthesize and communicate high-level insights effectively to senior management internally and externally.</li><li>Demonstrated strong negotiation skills.</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Director, Transactions

Site Name: USA - Massachusetts - Cambridge, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence Posted Date: Mar 8 2024 The Director, Transactions is a senior role in the R&D organization at GSK, where the role holder supports global business development and licensing initiatives and has a direct impact on the success of the Oncology strategy and portfolio. The Transactions team sits within global business development and is responsible for leading the negotiation and execution of collaborations, including discovery partnerships, clinical collaborations, licensing agreements and acquisitions. By effectively synthesizing and communicating the merits of potential investment opportunities, the role holder will enable enterprise decision-making related to business development opportunities. The successful candidate will have a strong scientific background, proven project and people leadership, business and strategic acumen and excellent communication skills. A strong understanding of the deal-making process in the industry is required as the role holder will be responsible for leading or supporting transactions-related activities, with a particular focus on companion diagnostic development and commercialization agreements. In addition, the candidate will have an ability to engage and collaborate across organizational boundaries with an entrepreneurial attitude by acting with urgency and agility. Key Responsibilities : This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following <ul><li>Serving as the internal lead, or in a supporting role, in both preparation and presentation of transactional aspects of each business case for senior management with support from functions across the business, including legal and corporate development.</li><li>Co-lead, with the Search & Evaluation team, the development of business case assessments and recommendations of external opportunities, including deal proposals, valuation, deal status, and key issues of the transaction to GSK governance bodies for endorsement.</li><li>Leads and/or supports the drafting of non-binding term sheets and serves as a key point of contact with the external partner throughout the deal process from submission of NBTS to signature. </li><li>Working with key stakeholders and cross-functional teams to ensure effective communication, efficient decision-making, to support completion of transactions in a timely manner.</li><li>As appropriate participates in Joint Steering Committees of major Strategic collaborations with Alliance Management colleagues to provide effective decisions and drive a successful external portfolio of projects.</li><li>Establishes and maintains a broad network of internal and external stakeholders and maintains a high level of external visibility</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Advanced degree in science, law or business (e.g., MS, LLM, MBA, PhD, JD, MD)</li><li>5+ years of experience in life sciences industry and 3+ years of relevant biopharma business development transactions experience (including companion diagnostic development and commercialization agreements) in leading multiple closed deals (deal sheet required).</li><li>Experience integrating scientific knowledge into business model and analyzing sales forecasts, P&Ls, risk analyses, and company valuations.</li><li>Experience building successful internal/external global partnership and collaboration relationships. </li><li>Expertise in reviewing and editing contracts and providing direction to Legal team members in term sheets and contracts.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Strong analytical, communication, negotiation, and leadership skills, with demonstrated ability to synthesize and communicate high-level insights effectively to senior management internally and externally.</li><li>Experience interacting and communicating effectively with senior executive teams.</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Director, Transactions

Site Name: USA - Pennsylvania - Philadelphia, Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: May 1 2024 Job Purpose The US Medical Affairs (USMA) Sr. Medical Lead, Respiratory Portfolio will drive senior scientific leadership with strong and compliant medical strategy and exemplary medical performance as part of an integrated brand ambition. Deliver insight generation and builds plans for evidence needed in partnership with Medical Commercialization, Market Access, and Value Evidence & Outcomes - US and Globally. The Sr. Medical Leader is accountable for the USMA strategic plans that support multiple in-line and pre-launch assets in a portfolio of disease areas, including new indications. The Sr. Medical Leader partners closely with Global Respiratory Medical Affairs VPs/Heads of the Respiratory Disease areas, Global R&D Respiratory area leads, Regulatory area leads, and US VP & Head, Marketing. The Sr. Medical Leader is a core member of USMA TA Leadership team, US BU Leadership Team and Commercialization Strategy teams, and Global Medical Affairs strategic boards. The Sr. Medical Leader is also accountable for ensuring evidence generation (Phase IIIb, IV, VEO) and publications plans meet US needs and address unmet patient needs. This role reports to the VP & Therapeutic Area Head, US Medical Affairs Key Responsibilities <ul><li>Lead a team of US medical affairs senior directors with responsibilities for multiple assets in-line and launch readiness disease areas (12-24 months pre-authorization).</li><li>Ensure novel and aligned medical objectives are thoughtfully incorporated into Global Respiratory Medical Affairs plans and US Integrated Brand Strategy to address unmet patient/provider needs and support strategic imperatives at the enterprise level.</li><li>Create strong collaborative partnerships internally with key stakeholders: Global VP/Heads Medical Affairs, VP US Marketing, Global R&D Clinical Development area leads to foster strong communication, understanding, and advocacy for the US and Medical Matrix Teams for in-line and pre-launch assets and disease areas.</li><li>Accountable for building strong priority external relationships and scientific engagement with key external experts, academic accounts, societies, patient advocacy groups in respective disease areas in support of USMA Portfolio-Level strategic engagement goals.</li><li>Provide leadership for regulatory agency support as needed with FDA, label reviews, safety discussions, etc.</li><li>Work in partnership with central teams, to optimize plans in support of a reimbursable file and life cycle strategy.</li><li>Share medical insights and advocate with cross-functional partners to shift strategy and plans (US, Commercial, Global, Clinical Development, Regulatory) as needed and act based on informed US feedback from external stakeholders, including changes to protocol design, publication planning, evidence generation, integrated strategic plans, etc.</li><li>Accountable for review of US VEO plans for in-line and pre-approval (12-24 months) in partnership with US VEO business partner and input into novel evidence generation to meet US needs. &bull; Help define strategic areas of interest and provide leadership to ensure US Investigator Sponsored Studies are moving through internal strategic and process pathways. Advise on development of US collaborative trials.</li><li>Establishes exemplary collaboration with VP, US Marketing to ensure strategic alignment with Internal Brand Commercialization Teams within US Business Unit.</li><li>Provide medical leadership and decision making for Promotional Review Committee escalations. &bull; Provide US medical input and expertise into potential BD&L activities related to respective disease areas. &bull; Responsible for leading and developing teams and people including recruitment and talent reviews. &bull; Accountable for financial planning and operational budget goals for in-line asset plans</li></ul>Why you? Basic Qualifications: <ul><li> PharmD, PhD, or allied health professional with advanced scientific degree </li><li> Must have US Medical Affairs leadership experience and US (or Global) asset launch experience </li><li>5+ years of Medical Affairs Experience</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> Medical Doctor Degree </li><li> Clinical and industry expert in the specified therapeutic area </li><li> Demonstrated success in inspiring/leading/managing teams and cross-functional work </li><li> Drug development (early through late stage) experience with knowledge of GCP regulatory/ market access and reimbursement requirements. </li><li> US Medical Affairs and life cycle management preferred, including launch support requirements. </li><li> Demonstrated ability to build strong internal and external networks with superior external stakeholder management skills across clinical, scientific, population health, policy, and regulatory </li><li> Significant disease and therapeutic area knowledge. </li><li> Robust understanding of US promotional codes/ regulations; previous involvement in review and approval processes </li><li> Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment. </li><li> Excellent presentation and media skills for both internal and external audiences. </li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

USMA Senior Medical Lead, Respiratory Portfolio

Site Name: USA - Pennsylvania - Upper Providence, Cambridge 300 Technology Square, Stevenage Posted Date: May 1 2024 We are seeking a talented and motivated individual to join our team as an Investigator in Applied Genetics. The successful candidate will have experience in human genetics, statistical genetics, genetic epidemiology, or a related discipline, and will be excited to apply their expertise to the development of new medicines. The Investigator will be responsible for evaluating genetic evidence in support of therapeutic target hypotheses and effectively communicating their results and interpretation to peers and leaders. They will have experience working in multi-disciplinary teams to answer complex scientific questions. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... <ul><li> Apply expertise in human genetics, statistical genetics, genetic epidemiology, or a related discipline to support the development of new medicines. </li></ul><ul><li> Evaluate genetic evidence to support therapeutic target hypotheses and provide clear and concise communication of results and interpretation to peers and leaders. </li><li> Collaborate effectively in multi-disciplinary teams to answer complex scientific questions. </li><li> Demonstrate initiative in identifying and implementing creative solutions to address challenging scientific questions. </li><li> Work with agility to adapt to changing priorities and timelines. </li><li> Participating in project teams with GSK scientists and external collaborators. Be responsible for effective communication of genetic findings, with expert interpretation, to relevant stakeholders and project teams. </li><li> Contribute to the developing science of drug target identification and validation, providing scientific expertise to advance science at GSK. </li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> Ph.D in human genetics, statistical genetics, genetic epidemiology, or related science/math discipline. </li><li> Experience in large-scale population based genetic studies, (e.g., GWAS and WES/WGS approaches.) </li><li> Experience evaluating and integrating genetic and genomic data to evaluate strength of causal genetic evidence </li><li> Experience with programming/scripting in R or Python</li><li> Experience with key genetics databases and resources </li><li> Experience working in multi-disciplinary teams to answer scientific questions. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> Proactive and innovative mindset with the ability to identify and implement creative solutions. </li><li> Strong problem-solving and analytical skills. </li><li> Ability to work flexibly and adapt to changing priorities and timelines. </li></ul><ul><li> Passion for advancing the science of drug target identification and validation. </li><li> Excellent communication skills to effectively convey complex scientific concepts to peers and leaders </li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Investigator (Applied Genetics)

Site Name: USA - District of Columbia - Washington Dc Posted Date: May 1 2024 Location: On-site at the Washington, DC office. Relocation assistance will not be provided. The Manager, Public Policy role is a key member of the US Public Policy team. The Manager will work closely with Policy Directors as a thought partner on reimbursement and federal prescription drug policy issues. He/she will work closely across the GSK Government Affairs and Public Policy (GAPP) team to shape the health policy environment and advance GSK's policy agenda. The position will: <ul><li>Monitor and track reimbursement and federal policies relevant to the GSK's portfolio and conduct in-depth research and analysis on federal legislation and regulations to extract key business insights.</li><li>Develop informative slide deck presentations, research briefs, advocacy materials, and other relevant content to effectively communicate insights.</li><li>Help support critical internal stakeholder relationships within GSK including the business units, US Legal, US Market Access team, US Medical Affairs, and GSK Global teams.</li><li>Help support critical external stakeholder relationships with key trade association workgroups, relevant consultants, and vendors.</li></ul> The areas of remit within the purview of the Manager, Public Policy include, but are not limited to: <ul><li>In partnership with the Policy Directors, c ontribute to the development and implementation of GSK's overall policy agenda in the US. </li><li>Providing insight and guidance to GAPP and the business units on reimbursement and federal policy developments, including building relevant policy positions and advocacy materials to advance priorities.</li><li> Collaborate with colleagues across the business units and participate in internal matrix teams to assess the support needed by GAPP to help drive business needs. </li><li> Support the launch and marketing teams and provide policy support for business strategy development across inline and pipeline products. </li><li>Support policy and advocacy strategies, including the development and approval of materials, in conjunction with relevant matrix partners the business units, US Legal, US Market Access team, US Medical Affairs, US Communications team, and GSK Global teams.</li><li> Provide support for external policy forums (BIO, PhRMA, etc.) and represent GSK thought leadership on priorities. </li><li> Serve as a conduit to policy consultants and internal GSK stakeholders; maintain a network of external consultants to monitor and assess evolving program and policy changes as relevant to the business. </li><li> Help support the Policy Directors m aintain alignment with GAPP leadership team on business units' priorities and strategy.</li></ul> Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor's degree</li><li>4+ years' experience in federal policy, government, consulting, or similar experience, including prior health policy and pharmaceutical experience or working within government agencies (e.g. HHS, CMS).</li><li>Experience managing several projects at one time.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Advanced degree (e.g. MPH).</li><li>Ability to synthesize and effectively communicate complex, disparate issues in a clear, concise manner through written communication or verbally.</li><li>Evidence of the ability to be a self-starter with a proactive approach.</li><li>Experience in self-management of time and work prioritization without oversight.</li><li>Evidence of excellent written, verbal, and interpersonal skills.</li><li>An understanding of current healthcare and biopharmaceutical industry issues, including knowledge of medical and pharmacy drug benefit dynamics.</li><li>Demonstrated analytical and independent problem-solving skills; ability to exercise sound, independent judgment.</li><li>Demonstrated ability as a project manager, collaborator, and individual contributor.</li><li>Experience presenting to, communicating with, and influencing senior leadership.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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