Hands-on experience with cell therapy technologies
Deep knowledge of clean room designs and validation
The Senior Specialist supports the production of personalized cell therapy products for global clinical trials and commercial supply at the CTO Summit, NJ site
Job Summary
The Senior Specialist supports the production of personalized cell therapy products for global clinical trials and commercial supply at the CTO Summit, NJ site.
This role requires leading qualification and validation activities including Aseptic Process Simulations, PPQ, and Continued Process Verification to ensure regulatory compliance.
Bristol Myers Squibb offers a wide variety of competitive benefits including health coverage, financial well-being programs, and flexible time off options.
Matching Summary
The Senior Specialist 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: Health, dental, vision, 401(k), paid time off
Skills & Requirements
Must-have
Expert knowledge of GMP and quality systems
Hands-on experience with cell therapy technologies
Deep knowledge of clean room designs and validation
Experience with Change Controls, CAPAs, and Deviations
Ability to work in ISO 5, 7, and 8 controlled environments
Nice-to-have
Strong leadership skills in multi-project settings
Excellent authorship and technical review capabilities
Proven ability to manage shifting priorities
Experience with single-use technologies and closed systems
Key Requirements
Bachelor's Degree in science or engineering required
3+ years of manufacturing support in biopharmaceutical industry
1+ year leading or executing process validation activities
Familiarity with 21 CFR Part 11 and FDA/EMA regulations