Parenteral ExM MS&T Principal Scientist

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

Benefits offered by this job

Flexible Time Off

Job summary

Bristol Myers Squibb in New Jersey is seeking a Principal Scientist to lead external manufacturing support for parenteral drug products. You will drive CPV and OPEX initiatives at CMOs, act as the site implementation lead for technology transfers, and guide investigations and CAPA for deviations.

You will also contribute to CMC documentation and regulatory responses while coordinating change requests across multiple sites and functions.

Qualifications

• Broadened knowledge of sterile/parenteral manufacturing and regulatory requirements.
• Experience in CPV, change management, and risk assessment.
• Strong collaboration with QA, procurement, and product development.

Responsibilities

• Act as Process Owner: drive CPV and OPEX at CMO sites to improve process robustness.
• Serve as Technical Point of Contact for PIP transfers and commercial manufacturing.
• Lead investigations and CAPA for out-of-trend results and deviations.
• Contribute technical input to CMC documents and regulatory responses.
• Coordinate change requests and complex deviations across sites.
• Represent MS&T on cross-functional project teams with QA and Supply Chain.

Skills

Process Owner

OPEX

CAPA

PIP support

Statistical analysis

GxP & cGMP

Education

Bachelor's in Chemical Engineering

Master's or PhD preferred

Tools

Minitab

JMP

DoE

QbD

pFMEA

Ishikawa

Job description

Bristol Myers Squibb in New Jersey is seeking a Principal Scientist to lead external manufacturing support for parenteral drug products. You will drive CPV and OPEX initiatives at CMOs, act as the site implementation lead for technology transfers, and guide investigations and CAPA for deviations.

You will also contribute to CMC documentation and regulatory responses while coordinating change requests across multiple sites and functions.