Biopharmaceutical Product Owner, NPI
- Weston, MA
Site Name: USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - King of Prussia
Posted Date: Aug 16 2020
Are you seeking an opportunity to leverage your expertise to work with and influence CMOs; apply your scientific knowledge to enable successful tech transfer, maintain the product throughout the life cycle and meet the demands of the supply chain to provide quality product to the patient? If yes, our Biopharmaceutical Product Owner, NPI opportunity may be the right position for you to explore.
In this role, you will join a team of scientists and engineers supporting new product introduction (NPI) of late stage biopharmaceutical assets into commercial manufacturing settings (internal and/or external). For products where the DS is manufactured at CMOs, this role will be the technical lead to ensure that process robustness and ongoing commercial manufacturing is effectively managed.
Additional responsibilities may include leadership of key improvement initiatives within the department and working with our partner organizations on delivery of aligned objectives. In addition, as a technical expert will provide leadership for technology transfer and commercial manufacturing operations, driving technical innovation for second generation processes, and effectively interfacing with R&D in support of portfolio projects and new product introductions, providing early input into design selection and manufacturability considerations. This position will focus on drug substance support, with demonstrated experience in upstream and downstream processes.
In partnership with R&D and Pharma Supply Chain (PSC), the incumbent will work to implement standards of quality by design (QbD) into robust manufacturing operations, maintaining knowledge of latest industry trends and becoming an advocate in the external community. The position requires the ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff members
Note: Future expectations for travel will vary based on portfolio needs, estimating ~ 10-20%. This position will begin as 100% remote. As circumstances evolve this role will eventually involve some on site work.
We are looking for professionals with these required skills to achieve our goals:
- BS/MS/PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or or other similar technical or life science subject area.
- Minimum of 7 years biopharmaceutical / pharmaceutical industry experience in technical support of clinical/commercial manufacturing and/or process development.
- Experience in program management and technology transfer to manufacturing sites.
If you have the following characteristics, it would be a plus:
- Experience in technical support of commercial manufacturing sites (internal and to external CMO), leadship in process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management), and knowledge management.
- Experience in unit operations including mammalian cell culture, filtration, chromatography, and UFDF.
- Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design. Ability to support due diligence activities.
- Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
- Broad and integrated knowledge and experience that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.
- Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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.
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