The role supports the production of personalized cell therapy products for global clinical trials and commercial supply at the CTO Summit, NJ site
Job Summary
The role supports the production of personalized cell therapy products for global clinical trials and commercial supply at the CTO Summit, NJ site.
Candidates must lead qualification and validation activities including PPQ, APS/APV, and CPV programs while ensuring strict adherence to GMP and regulatory requirements.
Bristol Myers Squibb offers a wide variety of competitive benefits including health coverage, financial well-being plans, and flexible time off options.
Matching Summary
The role supports the production of personalized cell therapy products for global clinical trials and commercial supply at the CTO Summit, NJ site.
Salary
Base: $86,490 - $104,803; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off
Skills & Requirements
Must-have
GMP and 21 CFR Part 11 compliance knowledge
Process Performance Qualification (PPQ) execution
Aseptic Process Simulation/Validation experience
Cell therapy manufacturing facility operations
Root cause analysis and CAPA implementation
Clean room gowning in ISO 5, 7, and 8 areas
Nice-to-have
Subject Matter Expertise in validation lifecycle
Experience with single-use technologies
Strong cross-functional collaboration skills
Continuous process improvement mindset
Ability to work independently with minimal direction
Key Requirements
Bachelor's Degree in science or engineering required
3+ years of biopharmaceutical manufacturing support experience
1+ year leading or executing process validation activities
Expert knowledge of GMP and quality systems concepts