Senior Director, Head of Potency and Impurity Assay Development
Bristol Myers Squibb
Full-time
Remote friendly (New Brunswick, NJ)
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 leads the Biologics Development team's strategy for potency and impurity assay development. This role orchestrates and executes CMC potency and impurity strategies, manages key milestones from pre-clinical to commercial stages, and oversees the development, validation, and transfer of analytical methods.
Requirements
- PhD or Master's/Bachelor's degree
- 15+ years of biotechnology experience
- Significant leadership and people management skills
- Deep understanding of molecular mechanisms
- Expertise in CMC potency and impurity development
- Knowledge of cGxP and regulatory filings