Director, Sterility Assurance, Cell Therapy Technical Operations

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Title: Director Sterility Assurance, Cell Therapy Technical Operations

Location: Summit, NJ, Devens, MA, 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.

The Director of Sterility Assurance, Cell therapy technical Operations reports to the Executive Director, Drug Product Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide technical oversight to drug product and vector sites as the 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 as the Global SME and will develop global technical standards for cell therapy sterility assurance and deploy the standards to site MS&T at internal and external sites. The Sterility assurance team will be accountable for developing sterility assurance standards, process qualification strategy and framework to support clinical and commercial manufacturing across the CT network.  The Team is accountable for implementation of this guidance and strategies in a consistent manner across products and sites and ensuring that these standards are reflected in the quality system.

The Cell Therapy Lead 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 roles 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. The person will own the accountability for the Sterility function by providing oversight of all the validation activities, including providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point of Contact for sites and will work with the sights to provide sterility assurance guidance and oversight.

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.

Key Responsibilities
Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry 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 sterility assurance investigations, regulatory inspections/submission/IR responses.  
• Support CMC authoring for relevant sections related to sterility assurance.
• Develop and deploy global standards with respect to Aseptic process simulation (APS), sterile filtration, clean room classification.
• Promot