Quality Control Microbiology Principal Scientist

Role

Serve as a microbiology SME supporting GMP testing and lifecycle management of biopharmaceutical products at Bristol Myers Squibb.

Responsibilities

• lead method transfers
• validations
• verifications
• author and review GMP documentation
• investigate deviations, deviations, and CAPAs
• represent QC in audits and regulatory inspections
• drive continuous improvement initiatives
• mentor colleagues on microbiological methods
• manage data using LIMS and ELN systems

Requirements

• Bachelor's in STEM (microbiology preferred)
• 10+ years of cGMP experience in biotechnology, cell therapy, or similar regulated environment
• proven expertise in microbiological testing, regulatory compliance, and quality systems
• prior ownership of cross-functional programs and project management skills

High-Value

microbiology, GMP testing, method validation, microbiological investigations, regulatory audits, biotech or cell therapy products, lifecycle support.