Associate Director, Aseptic Operations & Training (CGT)
Core
Lead the Aseptic Operations and Training team to support scalable clinical and commercial manufacturing of Cell & Gene Therapy (CGT) products across multiple Boston-area sites.
Role type
Senior leadership IC (Associate Director) in CGT Manufacturing and Process Engineering
Builds
Scalable clinical and commercial CGT manufacturing operations
Domain
Biopharmaceuticals / Cell & Gene Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing leadership, aseptic operations, training strategy development, contamination control strategies, sterilization and cleaning validation, regulatory compliance (Annex 1), process improvement, KPI management
Preferred skills
Advanced degree in Engineering/Microbiology/Biotechnology, digital transformation in manufacturing, proficiency in eBR/DCS/SCADA/Pi/ERP/QMS systems
Technologies
eBR, DCS, SCADA, Pi, ERP, QMS
Responsibilities
Build and mentor the Aseptic Operations and Training team; Develop and deploy GMP Manufacturing Training Strategy; Oversee Aseptic Process Simulation (APS) and Aseptic Personnel Qualification (APQ) programs; Act as SME for Contamination Control Strategies and cleaning validation; Lead initiatives to improve particulate control in single-use systems; Monitor industry trends in aseptic processing and cleaning technologies
Seniority
Senior, hands-on IC with strategic oversight
