Associate Director, Technical Product Lead, Cell Therapy Technical Operations (CTTO)

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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: Associate Director, Technical Product Lead, Cell Therapy Technical Operations (CTTO)

Location: 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 Associate Director, Technical Product Lead (CTTO), will be responsible for technical oversight of Cell Therapy products including ownership of process control strategy, and life cycle management activities for commercial products and post-commercial support and implementing process improvements for cell therapy processes.

Key Responsibilities:

• Own and maintain the process control strategy.
• Maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
• Serve as the single point of technical governance to the Technical Product Team (TPT) to manage all technical aspects of product lifecycle management.
• Develop product technical strategies including manufacturing requirements, process improvement plans, 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, product comparability and second line support of technical/scientific process issues.
• Collaborate with Technical Development groups on lifecycle improvements.
• Provide technical content for significant documents such as 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 process capability and to increase robustness and sustainability.
• Present complex technical topics internally and externally.
• Provide scientific leadership on technical teams for life cycle management changes and process improvements.
• Leadership/mentorship for direct reports to support business goals and career development, as required.
• Collaborate with Manufacturing, site MSAT, PS&T, other functions, and technical development groups to achieve GMP process solutions.
• Provide technical content and author regulatory submissions and responses to information requests by regulatory agencies.
• Provide technical guidance to support launches of new markets and products.

Qualifications & Experience:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing:  Minimum of a Bachelor’s with 12+ years or a Master’s degree with 10+  years or Ph.D. degree with 8+ of experience
• 2+ years experience managing direct reports and/or matrix teams.
• Strong understanding of bioprocess unit operations, especially cell culture.
• Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations
• A strong mindset for high-quality, meticulous, and consistent execution of manufacturing processes and/or analytics
• Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and heal