Aseptic Process Design Leader

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

Job summary

Bristol Myers Squibb in New Brunswick, NJ seeks an experienced professional to lead aseptic process development and lifecycle management across manufacturing sites. You will design, qualify, and optimize aseptic systems, support media fills, and ensure compliance with cGMP and regulatory standards.

Travel up to 25% is required; you will partner with Quality, Manufacturing, Engineering, MS&T and Validation teams to deliver projects and drive continuous improvement in sterile operations.

Qualifications

• Required:B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry,Chemical Engineering, Biotechnology or a related scientific discipline.
• 5-10+ years in aseptic/sterile manufacturing.
• Experience with cleanroom and aseptic operations environments.
• Strong knowledge of aseptic processing, sterile manufacturing, and contamination control.
• Familiarity with cGMP FDA/EU/ICH principles and regulatory expectations.
• Ability to perform root cause analyses, risk assessments, and process troubleshooting.
• Data analysis and process performance evaluation skills.
• Experience with equipment commissioning and startup.
• Process optimization and continuous improvement track record.
• Leadership and cross-functional collaboration capabilities.

Responsibilities

• Design and develop aseptic manufacturing processes, including fill/finish operations.
• Define cleanroom layouts, material/personnel flows, and environmental control strategies.
• Support equipment evaluation for aseptic manufacturing (filling lines, isolators, RABS).
• Lead process optimization and technology transfer from development to manufacturing.
• Support commissioning, qualification (IQ/OQ/PQ) and validation strategies.
• Ensure lifecycle monitoring and continuous improvement of processes.
• Provide SME guidance for APS, media fill programs, and regulatory readiness.
• Collaborate with Quality, Manufacturing, Engineering, MS&T and Validation on projects.

Skills

Aseptic processing

Sterile manufacturing

Cleanroom design

Fill/finish operations

Sterilization technologies

Process validation

GMP manufacturing systems

Contamination control

Root cause analysis

Data analysis

Equipment commissioning

Process optimization

Project management

Leadership

Education

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

Job description

Bristol Myers Squibb in New Brunswick, NJ seeks an experienced professional to lead aseptic process development and lifecycle management across manufacturing sites. You will design, qualify, and optimize aseptic systems, support media fills, and ensure compliance with cGMP and regulatory standards.

Travel up to 25% is required; you will partner with Quality, Manufacturing, Engineering, MS&T and Validation teams to deliver projects and drive continuous improvement in sterile operations.