Associate Director, Aseptic Process and Design
Core
Design and develop aseptic manufacturing processes, cleanroom layouts, and sterile processing systems to minimize contamination risks for pharmaceutical production.
Role type
Senior IC aseptic process and facility design engineer
Builds
Aseptic manufacturing processes, fill/finish operations, sterile processing systems, and cleanroom environments
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (specifically aseptic manufacturing processes and facility design)
Required skills
Aseptic processing, sterile manufacturing, contamination control, cleanroom design and operation, fill/finish operations, sterile filtration, sterilization technologies, process validation, GMP manufacturing systems, risk-based approaches, root cause analysis, data analysis, project management
Preferred skills
M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, or Biotechnology
Technologies
ISO classifications, FDA 21 CFR Parts 210/211, EU GMP Annex 1, ICH Q8/Q9/Q10, VHP, RABS, isolators
Responsibilities
Define cleanroom layouts and environmental control strategies; establish microbial critical process parameters and optimize yield; lead commissioning and qualification of aseptic systems; define enterprise APS/media fill strategy; assess microbial contamination risks and define mitigation strategies; ensure compliance with cGMP and regulatory guidelines; partner with cross-functional teams to deliver projects and lead capital projects
Seniority
Senior, hands-on IC with leadership and coaching capability
