Aseptic Process Design Leader

Bristol Myers Squibb; Dublin; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits

Wellbeing support

Flexible work options

Job summary

Bristol Myers Squibb is seeking an Associate Director for Aseptic Process and Design in Ireland. You will lead aseptic process development, cleanroom design, and validation strategies across sites, ensuring cGMP compliance and robust technology transfer to manufacturing.

Strong leadership and cross-functional collaboration are essential. The role requires 5–10+ years in aseptic manufacturing, deep knowledge of aseptic processing, and expertise in process validation, qualification, and lifecycle

Qualifications

• Requires B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or related field.
• 5–10+ years in aseptic/sterile manufacturing.
• Hands-on cleanroom and aseptic operations experience.
• Strong knowledge of aseptic processing, sterile manufacturing, and contamination control.
• Experience with process validation, qualification, and GMP systems.
• Familiarity with cGMP, FDA/EU/ICH guidelines.
• Excellent data analysis and problem-solving skills.
• Proven project management and cross-functional coordination.
• Leadership and coaching capabilities.

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.
• Support equipment evaluation and technology selection for aseptic manufacturing.
• Lead process optimization and scale-up, including technology transfer from development to manufacturing.
• Lead commissioning and qualification activities (IQ/OQ/PQ) for aseptic systems.
• Develop and execute process validation strategies and continued process verification.
• Implement APS/media fill programs and oversee regulatory alignment.
• Collaborate with Quality, Manufacturing, Engineering, MS&T and Validation teams on projects.

Skills

Aseptic processing

GMP knowledge

Root cause analysis

Data analysis

Cross-functional collaboration

Project management

Technical leadership

Communication

Continuous improvement

Leadership coaching

Education

B.S. in Microbiology/Pharmaceutical Sciences

M.S. in Microbiology/Pharmaceutical Sciences (preferred)

Job description

Bristol Myers Squibb is seeking an Associate Director for Aseptic Process and Design in Ireland. You will lead aseptic process development, cleanroom design, and validation strategies across sites, ensuring cGMP compliance and robust technology transfer to manufacturing.

Strong leadership and cross-functional collaboration are essential. The role requires 5–10+ years in aseptic manufacturing, deep knowledge of aseptic processing, and expertise in process validation, qualification, and lifecycle