Associate Director, Cell Therapy Comparability

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Title: Associate Director, Cell Therapy Comparability

Location: Summit, NJ or Seattle, WA

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

The Associate Director, Cell Therapy Comparability will lead comparability programs and collaborate with cross-functional global teams to support for late-stage and commercial cell therapy programs going through critical lifecycle changes, e.g., vector changes, drug product process changes, new manufacturing sites and suites establishment.

This individual will actively drive comparability strategies, anticipate bottlenecks, comparability risks, and proactively address critical issues while fostering a collaborative environment for the matrix team with key supporting functions. They will lead cross-departmental teams, plan risk assessments, and develop strategies for cell therapy comparability. This will involve collaborating with subject matter expert representatives from key functions, including analytical, process, manufacturing, quality, regulatory, etc., and key matrix leaders from CMC and Global Operation teams. Additionally, they will review and provide guidance on strategy in technical protocols and results, ensuring effective communication and execution of comparability across all CMC functional areas. They will play a key role in product lifecycle management, encompassing development, characterization, commercialization, and evolution of cell therapy products. This position requires a strong background in analytical comparability exercises, study design, statistical analysis, and summarizing strategies in technical reports, and communication with global health authorities with submissions.

Key Responsibilities:

• Drive the design and execution of autologous CART comparability strategy by leveraging in-depth cellular and viral vector product process and analytical knowledge, collaborating closely with cross-functional subject matter experts (SMEs) in CMC, Global Operation, Quality, and Regulatory.
• Lead the development of comparability risk assessments, establishment of acceptance criteria and justifications, drafting of comparability protocols, etc., in collaboration with biostatisticians and other cross-functional SMEs.
• Author reports that summarize comparability risk assessments, protocols, study design justifications, acceptance criteria, comparability study outcomes, conclusions, and other critical information.
• Collaborate with Regulatory CMC and other key functions to design appropriate regulatory submission and communication paths for the programs; and lead technical communications and documentations that summarize the strategy and results from comparability exercises.
• Utilize existing or develop new quality and technical risk assessment tools and templates to quantify the impact on product safety and efficacy through product quality and process performance assessment of the changes to be evaluated in comparability exercises.
• Maintain and strengthen relationships across functions, manufacturing sites, and development sites, demonstrating mature stakeholder management skills.
• Mentor and support other team members to ensure overall team success.

Qualifications & Experience:

• Ph.D, MSc or BSc in Analytical Science, Chemical Engineering, Biochemical Engineering or equivalent with minimum of 7 (PhD)/5 (MSc)/10+ (BSc) years relevant experience in drug product development, manufac