Aseptic Process & Design Leader

Bristol Myers Squibb; United States; On-site; USD 162,000 - 210,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Stock opportunities

Job summary

Bristol Myers Squibb seeks an Associate Director of Aseptic Process and Design to lead sterile manufacturing initiatives across US sites. You will design aseptic processing systems, drive qualification, validation, and lifecycle programs, and collaborate with Quality, Manufacturing, Engineering, MS&T, and Validation teams to deliver complex projects.

Travel up to 25% may be required. The role emphasizes regulatory readiness, continuous improvement, and strong data-driven decision making within

Qualifications

• Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or related scientific discipline.
• 5–10+ years in aseptic/sterile manufacturing.
• Hands-on experience in cleanroom and aseptic operations environments.
• Familiarity with cGMP FDA 21 CFR Parts 210/211, EU GMP Annex 1 / ISO 13408 and ICH Q8/Q9/Q10.

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.
• Establish CPPs and develop robust aseptic manufacturing formulas.
• Lead process optimization to improve yield, reliability, and sterility assurance.
• Support scale-up and technology transfer from development to commercial manufacturing.
• Lead or contribute to 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.

Skills

Aseptic processing

Sterile manufacturing

Contamination control

Cleanroom design

Fill/finish operations

Process validation

GMP regulatory knowledge

Root cause analysis

Data analysis

Project management

Leadership

Education

B.S. in Microbiology/Pharmaceutical Sciences/Biology/Biochemistry/Chemical Engineering/Biotechnology

M.S. preferred

Job description

Bristol Myers Squibb seeks an Associate Director of Aseptic Process and Design to lead sterile manufacturing initiatives across US sites. You will design aseptic processing systems, drive qualification, validation, and lifecycle programs, and collaborate with Quality, Manufacturing, Engineering, MS&T, and Validation teams to deliver complex projects.

Travel up to 25% may be required. The role emphasizes regulatory readiness, continuous improvement, and strong data-driven decision making within