The role is responsible for overseeing and driving continued compliance of the site contamination control program including facility design and aseptic process validation
Job Summary
The role is responsible for overseeing and driving continued compliance of the site contamination control program including facility design and aseptic process validation.
Bristol Myers Squibb offers a wide variety of competitive benefits including health coverage, financial well-being protection, and flexible time off options.
This position requires acting as a Subject Matter Expert during regulatory inspections and responding to all regulatory inquiries in a timely manner.
Matching Summary
The role is responsible for overseeing and driving continued compliance of the site contamination control program including facility design and aseptic process validation.
Salary
Base: $100,480 - $121,756 annually; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellness programs
Skills & Requirements
Must-have
Bachelor's degree in STEM field
6 years cGMP experience minimum
3 years QC Microbiology or sterility assurance
Advanced understanding of aseptic processing
Knowledge of FDA EMA USP regulations
Proficiency with quality management systems
Nice-to-have
Experience with cell therapy manufacturing
Internal and regulatory inspection experience
Strong critical reasoning skills
Global forum participation
Flexible and adaptable work style
Key Requirements
Minimum 6 years cGMP environment experience
At least 3 years in QC Microbiology or sterility assurance