Aseptic Process & Design Director | Global Impact

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

Benefits offered by this job

Wellbeing benefits

Retirement plan

Insurance (medical, dental, vision)

Flexible Time Off

11 paid holidays

Job summary

Bristol Myers Squibb is seeking a senior expert to shape enterprise sterility and microbial control across global manufacturing sites. The role involves defining strategies, leading regulatory interactions, and guiding CAPA processes to prevent contamination in sterile operations.

Qualified candidates will have extensive experience in aseptic process design, environmental monitoring, and regulatory submissions, with strong cross-functional leadership and global coordination capabilities.

Qualifications

• Bachelor's degree in Microbiology or related field.
• 12+ years in pharmaceutical manufacturing/quality/sterility assurance.
• Experience with aseptic process design, environmental monitoring, and regulatory submissions/inspections.

Responsibilities

• Define and maintain enterprise sterility and microbial failure models.
• Own the enterprise contamination control strategy aligned with regulatory expectations.
• Develop risk assessment methodologies and tools for global sites.
• Lead or support CAPA development for systemic contamination trends.

Skills

Risk assessment

Regulatory inspections

Cross-functional leadership

Aseptic processing

Education

Bachelor's degree in Microbiology

Tools

APS design

Job description

Bristol Myers Squibb is seeking a senior expert to shape enterprise sterility and microbial control across global manufacturing sites. The role involves defining strategies, leading regulatory interactions, and guiding CAPA processes to prevent contamination in sterile operations.

Qualified candidates will have extensive experience in aseptic process design, environmental monitoring, and regulatory submissions, with strong cross-functional leadership and global coordination capabilities.