Principal Scientist, Parenteral ExM & Process Excellence

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

Stock opportunities

Job summary

Bristol Myers Squibb in New Brunswick, NJ is seeking a dynamic Principal Scientist to oversee external parenteral manufacturing at CMOs across North America. You will lead CPV/OPEX initiatives, drive technical transfers, and coordinate complex CAPA activities to ensure robust, compliant drug product manufacturing.

The role requires deep expertise in sterile processes, cGMP, and risk assessment with a track record of cross-functional leadership and effective communication across sites and

Qualifications

• Recognized subject matter expert in sterile/parenteral manufacturing processes.
• In-depth knowledge of regulatory (cGMP, EHS) aspects of drug product manufacturing.
• Experience with DoE, QbD, and risk assessment frameworks.

Responsibilities

• Act as Process Owner: drive CPV and OPEX initiatives at CMO sites.
• Technical Point of Contact for CMO partners, including PIP support during tech transfers.
• Lead root cause analyses, CAPA development, and investigations for out-of-spec results.
• Contribute technical input to CMC documents and support regulatory responses.

Skills

Sterile manufacturing

CPV/OPEX

DoE/QbD

Regulatory knowledge

Education

BS degree

MS degree

PhD

Tools

Minitab

JMP

Job description

Bristol Myers Squibb in New Brunswick, NJ is seeking a dynamic Principal Scientist to oversee external parenteral manufacturing at CMOs across North America. You will lead CPV/OPEX initiatives, drive technical transfers, and coordinate complex CAPA activities to ensure robust, compliant drug product manufacturing.

The role requires deep expertise in sterile processes, cGMP, and risk assessment with a track record of cross-functional leadership and effective communication across sites and