cGMP Associate Director, Process Development
Core
Lead process development and optimization for cell and gene therapy products, including viral vector design, technology transfer to cGMP manufacturing, and assay qualification.
Role type
Senior IC Associate Director, Process Development (cGMP)
Builds
Cell and gene therapy products, viral vectors, and analytical assays for internal/external users
Domain
Biopharmaceuticals / Cellular and Gene Therapies
Required skills
cGMP compliance, process development, technology transfer, SOP/protocol authoring, vendor management, team leadership, risk mitigation, project management, quality management, CMC documentation
Preferred skills
Doctorate in biotechnology, cGMP laboratory SOP experience, vendor selection and engagement management
Technologies
cGMP facilities, viral vector production systems, analytical assay 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 technology transfer to cGMP manufacturing; author CMC documentation and SOPs; oversee lab setup and resource allocation.
Seniority
Senior, hands-on IC with management responsibilities