Senior Director, CTTO Tech Transfer

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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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Title: Senior Director, Cell Therapy Technical Operations Tech Transfer

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 Senior Director, Cell Therapy Technical Operations Tech Transfer provides technical and process leadership and ownership of the cell therapy manufacturing process for commercial products. This is a key technical role within BMS’s cell therapy technical operations division as we expand the growth of our approved commercialized autologous cellular biologics products to overcome tumor evasion and potentially eradicate cancer cells. This role will assume primary technical leadership for the manufacturing process of drug product for one or more CAR T programs. This includes establishing the requirements for the commercial manufacturing process, coordinating technical transfers to manufacturing and between sites, developing process qualification, process control and comparability strategies, supporting the authoring of technical sections of major regulatory documents and contributing to the overall CMC and commercial strategy.

The scope of the role includes providing ongoing technical oversight to manufacturing, defining and driving a long-term process improvement lifecycle plan and ensuring successful execution of the technical strategy. The role will work cross-functionally across technical operations and most closely with external IDMOs, and other functions within BMS such as process and analytical development, quality, regulatory, manufacturing and supply chain counterparts in coordinating the technology transfer of commercial programs. The role may assume supervisory responsibility for a junior technical team. This role will be a member of the Cell therapy CMC team. The incumbent will help drive the technology transfer, validation, qualification and comparability strategies and be viewed as a technical thought leader internally and externally in cell therapy drug product manufacturing technology.

Key Responsibilities:

• Own the technology transfer of the commercial assets including ownership of the tech transfer plan and final report
• Develop product technical strategies including manufacturing requirements, process improvement plans as part of the technology transfer and also help define the post approval life cycle management plans and ensure successful and timely execution working across functional groups.
• Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, and product comparability.
• Collaborate with Technical Development groups on lifecycle improvements for the commercial products.
• Provide technical content for significant documents such as tech transfer plan/report, PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.
• Perform and support data monitoring of manufacturing processes to understand successful tech transfer, process capability and to increase robustness and sustainability.
• Function as a subject matter expert for autologous T cell therapies and manufacturing technologies.
• Provide technical input an