Director, Biologics Process Engineering
- Weston, MA
Site Name: USA - Massachusetts - Waltham
Posted Date: Oct 7 2020
GSK is growing the Waltham, MA based Strategic External Development (SED) enterprise to deliver on our portfolio of transformative medicines to patients around the world. The externally focused SED enterprise will be an empowered, innovative and agile CMC development organization that will unlock the potential to rapidly deliver an increased number of transformative medicines to patients through exceptional relationships with trusted global partners.
The Strategic External Development enterprise has been built from the foundation of the legacy TESARO CMC development organization and has the responsibility of harnessing the global development and manufacturing capabilities of strategic partnerships and relationships to accelerate the availability of GSK's pipeline of transformative medicines for patients.
With an exciting project pipeline, an amazing team, partners at the ready, we are looking for a Process Engineering Leader who will play a critical role in developing and registering the company's pipeline of development-stage biologics candidates.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Lead technology transfer of biologics manufacturing processing as part of a cross-functional team to internal nodes and/or external contract manufacturing organizations
- Lead the effort in establishing a comprehensive biologics drug substance process performance qualification (PPQ) strategy for commercial registration.
- Responsible for establishing an integrated biologics drug substance process control strategy including developing capabilities are strategic partners and ensure smooth transition to the Strategic External Manufacturing group at the commercial stage
- Author, review and/or approve PPQ protocols and PPQ reports by collaborating with quality, regulatory and external CDMO business partner.
- Manage and oversee PPQ related activities at CDMO sites in close collaboration with Quality Assurance
- Collaborate with regulatory-CMC in defining technical content, related to drug substance, of module 3 for BLA/MAA submission and ensure submission timelines are met.
- Author and review responses to regulatory inquiry regarding BLA and MAA filings.
- Responsible for meeting PMCs and/or PMRs.
- Lead effort in defining strategy for product life cycle management including continuous improvement efforts and global market authorization strategy
- Keep abreast of the evolving global regulatory requirements and industry standard practices for biologics drug substance PPQ and BLA/MAA submission and approval.
- Collaborate with internal stakeholders and external business partners to achieve group, departmental and corporate goals.
- Partner effectively and transparently with internal stakeholders in the areas of Biologics Operations, Analytical Development, Biologics Drug Product Development, CMC Project Management, Quality Assurance and Quality Control, Regulatory Affairs, and Commercial Manufacturing and external CDMO business partners
Ph.D./MS in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline.
- Minimum of 12 years of biologics drug substance development experience.
- Demonstrated track record of leading and managing late stage biologics drug substance process development, process characterization, process performance qualification activities.
- Hands-on working experience in BLA/MAA drafting, submission and approval.
- Hands-on working experience in biologics product life cycle management.
- Strong knowledge of CMC regulatory requirements from IND filing to BLA/MAA submission and approval.
- Demonstrated track record of CDMO management in supporting manufacturing process development and GMP manufacturing.
- Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
- Strong communication skills: ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience.
- Self-motivated, with the ability to act with urgency and passion.
- Proven ability to work with at a high level of integrity, accuracy, and attention to detail.
- Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions.
- Resourceful, enthusiastic, innovative and results-oriented.
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
Our values and expectations are 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, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation
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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