Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects)
Bristol Myers Squibb
Full-time
Remote friendly (Devens, MA)
Worldwide
Operations
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Principal Scientist, Manufacturing Technology (Process Transfer, Validation and Projects)
Company: Bristol Myers Squibb
Job Overview
The Principal Scientist is a subject matter expert and process/project owner for biologic drug substance commercial technical transfers, process validations, and project portfolio.
Responsibilities
- Leading commercial biologics technical transfers
- Ensuring processes are designed and validated per cGMPs and regulatory guidance
- Driving process validation protocols and reports
- Contributing to CMC submissions
Requirements
- Bachelor's degree
- At least 6 years of relevant experience
- Technical execution in technology transfer and Process Performance Qualification
- Strong knowledge of quality systems