Associate Director, Aseptic Process and Design
Bristol Myers Squibb · New Brunswick, NJ +5 more
CMCFull-time$173k–$210kCompany career page
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Role summary
Bristol Myers Squibb seeks an Associate Director to design and optimize aseptic manufacturing processes, lead process validation and qualification efforts, and establish enterprise-wide strategies for sterile manufacturing and contamination control across multiple sites.
What they're looking for
- B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or Biotechnology
- 5–10+ years hands-on experience in aseptic and sterile manufacturing operations
- Expertise in cleanroom design, fill/finish operations, sterilization technologies, and contamination control
- Knowledge of cGMP, FDA 21 CFR Parts 210/211, EU GMP Annex 1, ISO 13408, and ICH Q8/Q9/Q10
- Demonstrated ability in process validation, qualification, root cause analysis, and risk assessments
- Strong project management, documentation discipline, and cross-functional collaboration skills
- Up to 25% travel required
What you'll be doing
- Design aseptic manufacturing processes including fill/finish operations, cleanroom layouts, and environmental control strategies
- Establish microbial critical process parameters and lead process optimization for yield and sterility assurance
- Lead or support commissioning, qualification, and validation of aseptic systems and production lines
- Define and oversee enterprise aseptic process simulation and media fill program strategy with governance and standards
- Ensure regulatory compliance and support FDA, EMA, and other health authority inspections with technical expertise
Privacy & handoff
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