cGMP Associate Director, Process Development
Core
Lead process development and optimization for cell and gene therapy products, including viral vector design, production, and technology transfer to cGMP manufacturing.
Role type
Associate Director, Process Development (cGMP)
Builds
Cell and gene therapy products, viral vectors, and associated manufacturing processes
Domain
Biotechnology / Cellular and Gene Therapies / cGMP Manufacturing
Required skills
Process development, cGMP compliance, technology transfer, SOP development, vendor management, team leadership, quality management, risk mitigation, project planning
Preferred skills
cGMP laboratory SOP experience, vendor selection and engagement management, deployment workbook development
Technologies
cGMP laboratory systems, viral vector production platforms
Responsibilities
Develop and implement strategies to mitigate risks in product manufacturing operations; oversee project plans for process and assay development/qualification; coach staff and coordinate hiring; manage vendor qualification and relationships; lead process optimization for cell therapy products; author CMC documentation; oversee lab setup and resource allocation
Seniority
Senior, hands-on IC with management responsibilities
