Senior Aseptic Operations & Quality Leader

Bristol-Myers Squibb Co; Princeton (NJ); On-site; USD 162,000 - 196,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

Job summary

Bristol Myers Squibb in New Jersey seeks an Associate Director, Aseptic Operational Support to provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments, partnering with MS&T on technology transfer and process design activities. The role does not own construction but ensures sterility assurance is built into the facility.

Key responsibilities include risk governance, aseptic and microbial design, and quality oversight of

Qualifications

• B.S. in relevant scientific discipline required.
• 10+ years in sterility, aseptic manufacturing or pharma quality.
• 4+ years in leadership or enterprise-level role.
• Deep expertise in aseptic processing, environmental monitoring, contamination control.
• Experience defending positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA).
• Proven track record in APS/CCS program design or overhaul at scale.
• Hands-on sterilization validation and single-use system qualification.

Responsibilities

• Review and approve global risk assessments and quality impact assessments related to contamination events.
• Lead and author high-complexity BTAs to support regulatory submissions and cross-site alignment.
• Develop investigation and inspection-readiness materials for aseptic and containment issues.
• Review and approve design packages, URS, DQ protocols for aseptic facilities and utilities.
• Define enterprise Quality standards for aseptic facility design and critical utilities.
• Provide oversight of facility, utility changes ensuring microbial risk control at design stage.
• Provide technical authority for aseptic design during capital projects and technology transfers.
• Oversee critical utility systems (WFI, PW, clean steam, HVAC) design, qualification and control.
• Collaborate with Engineering and Validation for IQ/OQ/PQ programs.
• Champion QbD and risk-based thinking across facility lifecycle.

Skills

Aseptic processing

Environmental monitoring

Contamination control

Microbial risk assessment

Regulatory inspections

QbD

Cross-functional collaboration

Education

B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related

Tools

Sterilization technologies

Job description

Bristol Myers Squibb in New Jersey seeks an Associate Director, Aseptic Operational Support to provide authoritative technical input on facility and utility design standards, risk assessments, and quality impact assessments, partnering with MS&T on technology transfer and process design activities. The role does not own construction but ensures sterility assurance is built into the facility.

Key responsibilities include risk governance, aseptic and microbial design, and quality oversight of