8+ years biopharmaceutical manufacturing experience
4+ years continuous process verification (cpv)
2+ years apqr reporting experience
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Bristol Myers Squibb is seeking a Senior Scientist in Biostatistics to support the Continuous Process Verification (CPV) and Annual Product Quality Review (APQR) for their cell therapy products in Summit, NJ. The role involves monitoring production parameters, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.
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Job Summary
This role supports the monitoring and trending of production parameters for personalized cell therapy products at the Summit, NJ facility.
The incumbent will provide multivariate analysis modeling to improve process understanding and ensure compliance with regulatory agencies.
Bristol Myers Squibb offers a competitive salary range of $112,840 - $136,733 along with comprehensive health coverage and flexible time off.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Senior Scientist in Biostatistics to support the Continuous Process Verification (CPV) and Annual Product Quality Review (APQR) for their cell therapy products in Summit, NJ. The role involves monitoring production parameters, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.
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Salary
Base: $112,840 - $136,733; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off
Skills & Requirements
Must-have
8+ years biopharmaceutical manufacturing experience
4+ years Continuous Process Verification (CPV)
2+ years APQR reporting experience
Proficiency in Python, R, JMP, or SAS
Expert knowledge of cGMP regulations
Nice-to-have
Experience with Operational Excellence and Lean Manufacturing