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, services, and programs that provide employees with resources to pursue goals at work and in personal lives.
The incumbent must maintain gowning qualification for aseptic processing areas and act as a Subject Matter Expert during regulatory inspections.
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; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Health coverage, 401(k), paid time off, and wellbeing support
Skills & Requirements
Must-have
Advanced understanding of Microbiology
Experience with aseptic processing
Knowledge of US and EU cGMP regulations
Application of quality risk management principles
Proficiency with eQMS systems
Nice-to-have
Knowledge of cell therapy manufacturing
Experience with internal and regulatory inspections
Strong critical reasoning and problem solving skills
Ability to work under pressure and meet timelines
Active participation in global forums
Key Requirements
Bachelor's degree in STEM field preferred
Minimum 6 years experience in cGMP environment
At least 3 years in QC Microbiology or sterility assurance roles