Associate Director, Cell Therapy Comparability Specialist
1 week ago
Bristol-Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform patients' lives. We are seeking an experienced Associate Director to lead our Cell Therapy Comparability program, driving comparability strategies, anticipating bottlenecks, and proactively addressing critical issues.
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.
- Lead the development of comparability risk assessments, establishment of acceptance criteria and justifications, drafting of comparability protocols, etc.
- 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.
- 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.
- Ph.D., MSc, or BSc in Analytical Science, Chemical Engineering, Biochemical Engineering, or equivalent with a minimum of 5 (Ph.D.), 7 (MSc), or 10+ (BSc) years of relevant experience in drug product development, manufacturing process, and analytical sciences.
- Experience in leading Cell & Gene therapy comparability projects is preferred, minimally with experience in leading biologics comparability projects.
- Demonstrated ability to effectively lead in cross-functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results-oriented, fast-paced matrix environment.
- Competitive compensation package, including a range of $156,000 - $195,000 (if based in Summit, NJ) and $166,000 - $208,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility).
- A wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
- A culture that values diversity, inclusion, and employee well-being, with opportunities for growth and development.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Seattle, Washington, United States Bristol-Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol-Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that transform patients' lives. We are seeking an experienced Associate Director to lead our Cell Therapy Comparability program, collaborating with cross-functional global teams to...
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