Aseptic Process & Design Executive Leader

Bristol Myers Squibb; New Brunswick (NJ); On-site; USD 219,000 - 265,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Vacation time (US)

Job summary

Bristol Myers Squibb in New Brunswick, NJ seeks a senior scientific leader to own enterprise sterility and microbial risk management across global sites. You will define risk taxonomy, CCS strategy, and QS governance, while guiding CAPA and regulatory interactions.

Role requires extensive experience in aseptic processing, environmental monitoring, and cross-functional leadership within GMP environments, with travel as needed. Strong communication with regulators is essential.

Qualifications

• Required: Bachelor\'s degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline
• 12+ years in pharmaceutical manufacturing, quality, sterility, or microbiology
• 7+ years senior leadership with direct accountability for sterile manufacture

Responsibilities

• Define and maintain the enterprise sterility and microbial failure model library, including risk classification taxonomy, contamination event typology, and risk-based sampling strategies
• Establish and own the enterprise-wide contamination control strategy (CCS) aligned with regulatory expectations (EU Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10)
• Develop and standardize risk assessment methodologies and tools used across global manufacturing sites
• Perform Global Microbial risk assessments and help build action plans with sites to remediate risk
• Provide authoritative review and sign-off on quality decisions that impact sterility assurance across the BMS network
• Serve as the enterprise escalation point for complex microbial and contamination-related quality events around Facilities, Equipment and Utilities
• Author technical BTAs and develop robust investigation materials for systemic microbiological issues
• Regulatory inspections support including expert testimony and documentation on aseptic process and microbial control matters
• Lead or support CAPA development and effectiveness monitoring for systemic contamination trends around Facilities, Equipment, and Utilities
• Define and govern APS/media fill strategy and oversee smoke study program to confirm airflow in critical zones
• Establish qualification frameworks for aseptic filling operations
• Provide hygienic equipment design leadership for contamination control by design

Skills

Regulatory inspections

Cross-functional leadership

Aseptic processing

Environmental monitoring

Risk assessment

Education

Bachelor's degree in Microbiology

Job description

Bristol Myers Squibb in New Brunswick, NJ seeks a senior scientific leader to own enterprise sterility and microbial risk management across global sites. You will define risk taxonomy, CCS strategy, and QS governance, while guiding CAPA and regulatory interactions.

Role requires extensive experience in aseptic processing, environmental monitoring, and cross-functional leadership within GMP environments, with travel as needed. Strong communication with regulators is essential.