Senior Director, Head of Potency and Impurity Assay Development
Bristol Myers Squibb
Full-time
Remote friendly (Devens, MA)
Worldwide
Other
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Senior Director, Head of Potency and Impurity Assay Development
Company Name
Bristol Myers Squibb
Job Description
The Senior Director, Head of Potency and Impurity Assay Development (PIAD) leads the strategic development of potency and impurity assays for biotherapeutics. This role involves orchestrating CMC potency and impurity strategy, managing milestones from pre-clinical to commercial stages, and collaborating across scientific and quality functions.
Key Responsibilities
- Developing industry-leading methods
- Ensuring GMP compliance
- Validating and transferring methods
- Providing scientific strategy for regulatory acceptance
Leadership and Experience
The position requires strong leadership, talent development (managing a team of 30-40), and extensive experience in CMC assay development and management.