Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Dec 15 2022
Are you looking for a challenging opportunity that allows you to leverage your technical expertise as a Process Technology Investigator.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Prepares and/or approves documents for use in technology transfer and manufacturing including cGMP master batch records. Prepares and/or reviews documents for regulatory submission, and leads response to questions when appropriate. Ensures that development and documentation are sufficient to support consistent production and regulatory filings.
Monitors processes providing on the floor support and troubleshooting during manufacture. Collects information and prepares/maintains a campaign summary database of process knowledge, to be leveraged as assets progress in the biopharmaceutical development cycle. Analyzes results fully and recommends follow-up actions. Key participant in troubleshooting activities.
Aids in the development of technology essential to large scale cGMP production. Solves process and equipment problems. Recommends equipment and procedures. Maintains awareness of new technology developments. Technically knowledge in areas of protein purification methods and/or cell culture/fermentation.
Coordinates activities between various Biopharmaceutical Development and Supply groups. Represents the department in project specific CMC teams and other multi-disciplinary matrix teams. Presents results/conclusions and contributes to the decision-making process within these teams.
Provides support for technology transfer from a CMO into GMP Operations. May provide oversight of manufacturing activities at CMO. Some international and domestic travel may be required (up to 50%). May support technology transfer into GSC facilities.
Prepares and may approve SOP's in areas of expertise.
May play a leadership role for specific cGMP compliance/readiness projects (ie. coordination of process scheduling, facility/equipment changeover, etc).
May lead or support Quality investigations or other Quality deliverables as appropriate.
Highly visible position with average level of accountability. Responsible for successful troubleshooting of production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns that support progression of the Biopharm R&D portfolio. Failure of a large scale cell culture or purification processes has ramifications throughout the research, development, and clinical organizations.
- Responsible for process technology transfer from Bioprocess development groups (internal and/or external) to the UME B38 Pilot Plant or contract manufacturing organizations. Monitors technical operations of the process through communication with Manufacturing Scientists. Coordinates efforts to transfer technology forward to contract manufacturers and other partners.
- Coordinates activities between Development and Manufacturing groups. Represents the Process Technology department at multi-disciplinary matrix teams. Presents results/conclusions at these meetings
- Responsible for successfully troubleshooting production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns.
- Responsible for ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings. Authors manufacturing and process sections of regulatory submissions and responses to regulatory questions.
- Aids in implementing technologies essential to large scale or cGMP production.
- Responsible for authoring and approval of batch documentation
- Provides training and guidance to Bioprocess Associates and less experienced personnel.
- Develops, evaluates, and supports introduction of technologies essential to large-scale cGMP production.
- Ph.D. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines or M.S. in these disciplines with a minimum four (4) years relevant experience, or B.S. in these disciplines with a minimum of six (6) years of relevant experience.
- 2 years experience with labpilot scale cell culture/fermentation operations which include, small scale seed scale up, bioreactor operations (single use knowledge desirable), alternating tangential flow filtration (ATF), depth filtration, centrifugation and media preparation.
- 2 years proficient in cGMPs and regulatory requirements.
- 2 years with technology transfer, process scale-up and manufacturing experience
- Excellent troubleshooting/problem analysis skills. Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable.
- Excellent written and oral communications skills.
- Excellent organizational, collaboration, and teamwork skills.
- Strong interpersonal and leadership skills. Solid team player able to function within collaborative- and team-based organization.
- Experience in project management and delivery, including ability to prioritize and forward plan courses of action.
- Works independently with minimal to no direct supervision.
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 impact the health of 2.5 billion people around the world in the next 10 years.
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.
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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-[Register to View] (US Toll Free) or +1 [Register to View] (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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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 [Register to View] site.