Quality Control Microbiology Principle Scientist
$133.28k - $161.5kBristol Myers Squibb
Bristol Myers Squibb seeks a Quality Control Microbiology Principal Scientist to serve as a subject matter expert in microbiological testing and processes. The role involves leading method validations, GMP testing support, regulatory compliance activities, and cross-functional quality initiatives across multiple products and stages.
Responsibilities
- Lead and execute method transfers, validations, and verifications for in-process and finished product testing
- Author, review, and approve GMP documentation including protocols, reports, and technical records
- Serve as subject matter expert on microbiological testing across multiple products and lifecycle stages
- Participate in investigations, deviations, CAPAs, and represent QC in regulatory inspections
- Drive continuous improvement initiatives and mentor laboratory colleagues on QC processes
Requirements
- Bachelor's degree in STEM field, microbiology preferred
- 10+ years cGMP experience in biotechnology, cell therapy, or regulated environment
- Demonstrated expertise in microbiological test methods and GMP processes
- Experience with method transfer, validation, and verification activities
- Knowledge of regulatory requirements and quality systems
- Proficiency with LIMS, ELN, and laboratory data analysis systems
Compensation: $133,280 - $161,504 base
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