Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Mar 9 2023
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 Technology Manager, you will Manage certain elements (such as upstream or downstream) of the transfer of drug substance biopharmaceutical production technologies from donors (R&D, third party clients or contract manufacturing organizations) to the Upper Merion site; or from the Upper Merion site to other biopharmaceutical manufacturing sites. Support the delivery of new biopharmaceutical applications and technologies, design and execute technical studies and protocols to confirm scale-up and successful technology transfer, analyze data and compile summary reports to make recommendations and successfully deliver process validation, deliver improvements to the existing supply chains supported by Upper Merion and the wider organization. Support efforts to continuously reduce product cost of goods and improve overall productivity while ensuring highly capable process control and product quality specifications are met for products supplied by the Upper Merion site.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Support the introduction and scale-up of primary manufacturing processes (drug substance) transferred from R&D or third party clients for specific products to the Upper Merion site. Support the establishment of resource requirements necessary to implement approved projects.
- Act as a technical representative for the Upper Merion site on the technology transfer teams and product development project team for specific products. Manage the relationships between donors (R&D or third party clients) and the Upper Merion site for specific products and communicate and influence stakeholders within R&D or third party client organizations.
- Propose strategies and priorities in planning technical transfer and process validation activities within areas of expertise.
- Responsible for process trend monitoring, analyses and assurance that key process parameters and attributes remain within control limits. Responsible for investigating and resolving process issues in a manner and timeframe consistent with production and quality goals for specific products.
- Provide technical training to production staff for new equipment and process technologies as required.
- Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and short-term process improvements within area of expertise.
- Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated at the Upper Merion site and that regulatory documents to support licensing of specific products are prepared.
- May need to contribute technical oversight of manufacturing operations, and prepare / coordinate technical studies for various manufacturing stages at the Upper Merion site.
- Contribute to the evaluation and feasibility/facility fit of prospective new products and technologies into the Upper Merion site (e.g. site impact assessments, or review of requests for proposal)
- Demonstrate the use of production system / performance management (Lean Six Sigma) tools and philosophies to prioritize deliverables and solve problems.
- Provide real-time and in-person process monitoring and technical oversight for a 24-7 manufacturing facility which will require off hours and weekend support as needed
We are looking for professionals with these required skills to achieve our goals:
- B.S./B.A. in biological or chemical engineering, biology, biochemistry or in an equivalent technical discipline
- 7+ years post-graduate experience in the Biopharmaceutical/pharmaceutical industry
- OR with a Master’s degree with 5+ years post graduate experience in the Biopharmaceutical/pharmaceutical industry
- Experience with current GMPs, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required
- Potential on call support may be required up to 25% off hours remotely or on site
If you have the following characteristics, it would be a plus:
- Master’s degree in biology, biochemistry or chemistry
- Emphasis on technology development and/or process technology transfer.
- Expert knowledge in biopharmaceutical technologies including: large scale cell culture technology, bioseparations, purification technologies, or pharmaceutical manufacturing of biologics and large molecules. Understanding of analytical technologies related to the above.
- Strong interpersonal and matrix leadership skills.
- Strong verbal and written communication skills.
- Strong analytical and critical thinking skills.
- Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
- Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of action. Effective at implementing decisions.
- Committed team player prepared to work within and embrace a team-based culture.
- Demonstrated leadership experience or potential.
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.