Senior Scientist, Parenteral ExM & Process Excellence

Bristol Myers Squibb EU Policy; New Brunswick (NJ); On-site; USD 122,000 - 148,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11+ paid holidays

Job summary

Bristol Myers Squibb is seeking a dynamic Principal Scientist to join External Manufacturing (ExM) Manufacturing Science & Technology (MS&T) in North America. You will provide expert leadership for parenteral drug product manufacturing at CMOs, driving process verification and manufacturing excellence.

You will lead investigations, support regulatory and CMC activities, manage complex change controls, and collaborate with QA, procurement, supply chain, SRM and product development to deliver

Qualifications

• Bachelor's degree in chemical/bioprocess/pharma science required; advanced degree preferred.
• Experience levels vary by degree: BS 9–12y, MS 6–9y, PhD 4–6y.

Responsibilities

• Drive CPV and OPEX initiatives at CMO sites to improve process robustness and reduce supply risk.
• Serve as Site Implementation Lead for CMO partners, supporting tech transfers and commercial manufacturing.
• Lead root cause investigations and CAPA development for out-of-spec results and deviations.
• Contribute technical input to CMC documents and support regulatory responses and inspections.
• Coordinate change requests and manage complex process deviations across sites.
• Collaborate with QA, Global Procurement, Supply Chain, SRM, and Product Development on cross-functional projects.

Skills

Sterile/parenteral manufacturing

Regulatory knowledge (cGMP)

Statistical analysis (Minitab/JMP)

DoE & QbD familiarity

Risk assessment (pFMEA, Ishikawa)

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Chemical Engineering / Bioprocess / related pharma science

Master's or PhD preferred

Tools

Minitab

JMP

DoE

Job description

Bristol Myers Squibb is seeking a dynamic Principal Scientist to join External Manufacturing (ExM) Manufacturing Science & Technology (MS&T) in North America. You will provide expert leadership for parenteral drug product manufacturing at CMOs, driving process verification and manufacturing excellence.

You will lead investigations, support regulatory and CMC activities, manage complex change controls, and collaborate with QA, procurement, supply chain, SRM and product development to deliver