Senior Director — Aseptic Process & Design Excellence

Bristol Myers Squibb; New Brunswick (IN); Hybrid; USD 219,000 - 284,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

Holidays and vacation policy

Job summary

Bristol Myers Squibb is seeking an experienced leader to drive enterprise sterility and microbial risk strategies across global manufacturing sites. You will shape risk assessment methodologies, support regulatory inspections, and oversee CAPA programs, partnering with QA, MS&T, Operations and External Partners.

We expect deep expertise in aseptic processing, environmental monitoring, and contamination control with a strong record of cross-functional leadership in a GMP setting.

Qualifications

• Required:Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
• Experience: 12+ years in pharmaceutical manufacturing, quality, sterility assurance, or microbiology within GMP
• Experience: 7+ years senior/leadership with sterile manufacture
• Experience: expertise in aseptic process design, environmental monitoring, contamination control, regulatory submissions/inspections
• Preferred: Advanced degree in Microbiology or related field

Responsibilities

• Define enterprise sterility and microbial risk classifications and sampling strategies.
• Own contamination control strategy aligned with regulatory expectations.
• Develop risk assessment methodologies and tools across global sites.
• Perform global microbial risk assessments and remediation action plans.
• Provide authoritative review on quality decisions affecting sterility across the network.
• Lead or support CAPA development and effectiveness monitoring.

Skills

Leadership

Regulatory inspections

Communication

Cross-functional collaboration

Environmental monitoring

Contamination control

Strategic thinking

Education

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline

Tools

FMEA

Fault tree analysis

Contamination control risk assessments

Job description

Bristol Myers Squibb is seeking an experienced leader to drive enterprise sterility and microbial risk strategies across global manufacturing sites. You will shape risk assessment methodologies, support regulatory inspections, and oversee CAPA programs, partnering with QA, MS&T, Operations and External Partners.

We expect deep expertise in aseptic processing, environmental monitoring, and contamination control with a strong record of cross-functional leadership in a GMP setting.