Lead, Aseptic Process Design & Facility Solutions

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

Benefits offered by this job

Flexible Time Off

Paid holidays

Job summary

Bristol Myers Squibb is seeking an Associate Director, Aseptic Process and Design in New Brunswick, NJ. The role leads aseptic process design, validation, and lifecycle management to ensure compliant, scalable manufacturing.

You will drive cross-functional efforts with Quality, Manufacturing, Engineering, MS&T and Validation teams, while guiding technology transfers and process improvements. Travel up to 25% is required as part of collaborating across sites.

Qualifications

• 5–10+ years in aseptic/sterile manufacturing.
• Hands-on experience in cleanroom and aseptic operations.
• Strong knowledge of aseptic processing, sterile manufacturing, and contamination control.
• Experience with process validation, qualification, and GMP manufacturing systems.
• Familiarity with cGMP, FDA/EU/ICH guidelines.
• Ability to perform root cause analysis and risk assessments.
• Excellent documentation discipline and attention to detail.

Responsibilities

• Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems.
• Define cleanroom layouts, material/personnel flows, and environmental control strategies to minimize contamination risks.
• Support sites in evaluating and selecting equipment and technologies for aseptic manufacturing (e.g., filling lines, isolators, RABS, and sterilization systems).
• Lead process optimization efforts to improve yield, reliability, and sterility assurance.
• Support scale-up and technology transfer from development to commercial manufacturing.
• Lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems and production lines.
• Develop and execute process validation strategies, including media fills and continued process verification.
• Ensure processes remain in control through lifecycle monitoring and continuous improvement.
• Provide SME guidance during regulatory inspections (FDA, EMA, PMDA, etc.).
• Collaborate with Quality, Manufacturing, Engineering, MS&T and Validation teams to deliver projects.

Skills

Aseptic processing

Sterile manufacturing

Cleanroom design

Process validation

GMP knowledge

Cross-functional collaboration

Leadership & coaching

Education

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

Job description

Bristol Myers Squibb is seeking an Associate Director, Aseptic Process and Design in New Brunswick, NJ. The role leads aseptic process design, validation, and lifecycle management to ensure compliant, scalable manufacturing.

You will drive cross-functional efforts with Quality, Manufacturing, Engineering, MS&T and Validation teams, while guiding technology transfers and process improvements. Travel up to 25% is required as part of collaborating across sites.