Sr. Manager / Associate Director, Global Sterility Assurance CTTO

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Title: Sr. Manager / Associate Director, Global Sterility Assurance CTTO

Location: Seattle, WA, Devens, MA or Summit, NJ

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.

The Sr Manager/Associate Director-  Sterility Assurance, Cell therapy technical Operations reports to the Director, Global Sterility Assurance within the Technical Operations group in the Cell Therapy Development and Operations (CTDO) organization. This role will provide technical oversight to drug product and vector sites as a global SME covering all aspects of sterility assurance for commercial cell therapy products manufactured globally via internal and external manufacturing sites. 

This role will serve a Global technical SME, supporting internal and external manufacturing sites for vector and drug product. The team is accountable for implementation of technical standards and strategies relating to sterility assurance, and ensuring sites are aligned in their approach to contamination control.  

This role will also cover life cycle management and implementation of new technologies and strategies with respect to sterility assurance providing SME guidance of support to CT manufacturing sites for routine manufacturing and major investigations.  The role will also provide guidance and support for all aspects of regulatory submission, inspections, IR responses process, equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for viral vector and drug product.  

This person will also support sterility assurance activities needed during design and build of new manufacturing plants and new product introductions ensuring compliance with the global health authority expectations and global standards. 

Key Responsibilities:

• Lead, develop and implement scientifically sound and fit for purpose sterility assurance standards and procedures based on current regulations, industry trends and best practices for cell therapy. 

• Create, maintain, deploy global cell therapy sterility assurance technical standards via quality system. 

• Promote innovative and efficient approaches to sterility assurance incorporating risk-based elements and considerations unique to cell therapy production. 

• Serve as global consultant for critical deviations in the network relating to c