Aseptic Process & Design Lead

Bristol Myers Squibb EU Policy; New Brunswick (NJ); On-site; USD 162,000 - 196,000; Full time

Benefits offered by this job

Flexible Time Off

Comprehensive benefits

Paid holidays

Job summary

Bristol Myers Squibb is seeking an experienced Associate Director to lead aseptic process design and lifecycle management in New Jersey. The role focuses on designing sterile manufacturing processes, optimizing yields, and ensuring regulatory compliance across sites.

The position requires collaboration with Quality, MS&T, Engineering, and Validation teams, plus travel up to 25%. Advanced degree in microbiology or related field is preferred and prior experience with regulatory inspections is

Qualifications

• Aseptic processing expertise and related regulatory knowledge.
• Experience with CPPs, media fills, and validation strategies.
• Strong collaboration with Quality, Manufacturing and Engineering teams.
• Ability to lead or contribute to technology transfers and CAPEX projects.

Responsibilities

• Design and develop aseptic manufacturing processes and cleanroom layouts.
• Lead process optimization to improve yield, sterility and reliability.
• Support qualification/validation activities (IQ/OQ/PQ) and lifecycle management.
• Provide SME guidance during regulatory inspections (FDA/EMA/PMDA).
• Travel up to 25% as needed.

Skills

Aseptic processing

Process development

Regulatory compliance

Cross-functional leadership

Education

MS in Microbiology/Pharmaceutical Sciences/Biology/Biochemistry/Chemical Engineering/Biotechnology

Job description

Bristol Myers Squibb is seeking an experienced Associate Director to lead aseptic process design and lifecycle management in New Jersey. The role focuses on designing sterile manufacturing processes, optimizing yields, and ensuring regulatory compliance across sites.

The position requires collaboration with Quality, MS&T, Engineering, and Validation teams, plus travel up to 25%. Advanced degree in microbiology or related field is preferred and prior experience with regulatory inspections is