Associate Director, Aseptic Operational Support
Core
Provide authoritative technical oversight and strategic direction for aseptic facility, utility, equipment, and process design to ensure sterility assurance and microbial control in pharmaceutical manufacturing.
Role type
Senior IC Quality SME (Aseptic Operations)
Builds
Aseptic facility design packages, utility qualification strategies, and contamination control frameworks for internal sites and external manufacturing partners.
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
Aseptic processing expertise, Contamination Control Strategy (CCS) development, Risk assessment (FMEA, HACCP), Regulatory inspection defense, Sterilization validation, Single-use technology qualification, Cleanroom design standards, Microbial risk assessment
Preferred skills
M.S. in Microbiology or Pharmaceutical Sciences
Technologies
EU GMP Annex 1, FDA Aseptic Processing Guidance, ISO 14644, ISO 11135/11137, PDA Technical Reports, RABS, Isolators, WFI, HVAC
Responsibilities
Review and approve global risk assessments and quality impact assessments for contamination events; Lead and author high-complexity Business Technical Assessments (BTAs) for regulatory submissions; Serve as Global Quality SME for aseptic facility and utility design review; Define enterprise-level Quality standards for cleanroom classification and airflow; Provide oversight for facility and utility qualification (IQ/OQ/PQ) programs; Own development of enterprise design standards for sterilization technologies and single-use systems.
Seniority
Senior, hands-on IC