Lead Scientist, Parenteral ExM & MS&T

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

Job summary

Bristol Myers Squibb is seeking a Principal Scientist in ExM MS&T to provide expert support for parenteral manufacturing at CMOs in North America. You will act as technical leader, drive CPV/OPEX, and ensure robust processes with a strong quality and regulatory focus.

Ideal candidates bring a PhD or relevant advanced degree, extensive sterile manufacturing experience, and demonstrated ability to influence across functions.

Qualifications

• Sterile/parenteral manufacturing subject matter expert.
• Deep knowledge of cGMP regulations and regulatory expectations.
• Strong statistical analysis skills with Minitab or JMP.
• Experience with DoE, QbD, risk assessment tools.
• Familiar with pFMEA and Ishikawa analysis.
• Proven ability to lead cross-functional teams.

Responsibilities

• Serve as technical lead for CPV and OPEX initiatives at CMOs.
• Act as Site Implementation Lead for tech transfers and manufacturing activities.
• Lead investigations and CAPA for out-of-spec results and deviations.
• Contribute to CMC documents and respond to health authority queries.
• Drive change requests and manage process deviations across sites.
• Collaborate with QA, Global Procurement, Supply Chain, and Product Development.

Skills

Sterile/parenteral manufacturing

Regulatory compliance (cGMP)

Statistical analysis (Minitab/JMP)

DoE / QbD / Risk assessment

pFMEA / Ishikawa analysis

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering or related

Master's or PhD preferred

Tools

Minitab/JMP

Job description

Bristol Myers Squibb is seeking a Principal Scientist in ExM MS&T to provide expert support for parenteral manufacturing at CMOs in North America. You will act as technical leader, drive CPV/OPEX, and ensure robust processes with a strong quality and regulatory focus.

Ideal candidates bring a PhD or relevant advanced degree, extensive sterile manufacturing experience, and demonstrated ability to influence across functions.