Associate Director - Vector Raw Materials

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Title: Associate Director - Vector Raw Materials

Location: Seattle, WA

At Bristol Myers Squibb we are reimagining the future of Cell Therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of Cell Therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

This is a global role and resides in the Raw Material (RM) team within the Cell Therapy Global Technical Operations (CTTO) department reporting into the Technical Director - Raw Materials.

The Raw Materials team is responsible for management of end-to-end raw materials, buffers, reagents, media, and single-use systems (SUS) used to support the vector nodes for commercial CAR-T therapies. The Associate Director - Vector Raw Materials will be responsible for management of raw material suppliers, deviations, change notifications and troubleshooting/ investigations related to materials used in vector manufacturing. This role will also provide strategic direction for the implementation of dual sourcing and technical transfer of vector manufacturing to new sites.

Responsibilities:

• Provide technical support on RM/SUS to the CT/Viral Vector (VV) manufacturing team. Strong focus on critical raw material supplier selection and critical material evaluations and issue resolution within the CT/VV network.
• Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing RM/SUS. Lead/support projects for qualification of new or alternate sourcing efforts for RM/SUS. Build strategy for lifecycle changes and raw material robustness. Collaborate with Manufacturing, Process Development, Analytical R&D, Quality Operations, MSAT network to ensure raw material oversight.
• Support internal and external manufacturing site(s) on investigations related to RM/SUS. Provide necessary technical analysis to support impact assessments for investigations and change control (internal and supplier change notification). Facilitate the development of appropriate mitigations and corrective actions.
• Support supplier quality assurance (SQA) on vendor management including change controls, audits, deviations, and Quality Risk Management (QRM) programs. Lead/support technical diligence and audits to RM/SUS supplier sites with cross-functional teams.
• Manage and/or mentor junior member(s) of the team. Support other members of the team with deviations, change control, and project support for RM/SUS for late stage clinical/commercial CT/VV.
• Author the RM/SUS section of the filing for new regulatory submissions. Author responses for Information Requests (IR) from regulatory bodies.  
• Travel - Approximately 10-15% travel may be required, domestically (primary) and internationally (potentially).

Qualifications & Experience:

• B.S./M.S. with 12 or more years development / manufacturing technologies for biologics, vaccines, or cell therapy. A combination or related experiences/degrees may also be acceptable.  A minimum of 2 years raw material experience is required (single use systems and/or media/ buffer/ reagents).
• Experience with Quality Management System (example: Deviation, CAPA, Change Management). Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Knowledge of GMP manufacturing practices and documentation requirements.
• Ability to assess risk and develop contingency plans for process risks. Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Detail oriente