Sr Manager, Microbiology & Sterility Investigations

Bristol-Myers Squibb; New Brunswick (NJ); On-site; USD 135,000 - 163,000; Full time

Benefits offered by this job

Medical insurance

Retirement plan

Flexible time off

Paid holidays

Job summary

Bristol Myers Squibb seeks a microbiology/sterility-focused professional to lead investigations, provide aseptic processing expertise, and support external manufacturing partners across sites. You will assess RCA, CAPA, and regulatory documentation, partnering with MS&T and Quality to ensure compliance and robust risk assessment.

The role requires 8+ years in microbiology/sterility within GMP pharmaceutical environments, strong technical writing, and experience with FDA/EMA frameworks.

Qualifications

• Bachelor’s degree in Microbiology or related field required.
• 8+ years in microbiology, sterility, or aseptic manufacture in GMP.
• Experience with regulatory frameworks: FDA/EMA/ICH.
• Strong technical writing and CAPA/RCA leadership.

Responsibilities

• Lead complex microbiology investigations and CAPA development.
• Provide SME guidance for sterility and aseptic processing.
• Review investigation reports for regulatory alignment.
• Support ExM partners and CMOs with risk assessments.
• Develop MQSA standards and training materials.

Skills

Technical writing

Aseptic processing

Environmental monitoring

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Microbiology or related field

Job description

Bristol Myers Squibb seeks a microbiology/sterility-focused professional to lead investigations, provide aseptic processing expertise, and support external manufacturing partners across sites. You will assess RCA, CAPA, and regulatory documentation, partnering with MS&T and Quality to ensure compliance and robust risk assessment.

The role requires 8+ years in microbiology/sterility within GMP pharmaceutical environments, strong technical writing, and experience with FDA/EMA frameworks.