CMC Product Leader, Senior Director - T1D
Core
Lead the Chemistry, Manufacturing, and Controls (CMC) functional team to develop and execute integrated CMC strategies for Type 1 Diabetes (T1D) cell therapy products, covering development, scale-up, technology transfer, validation, and commercialization readiness.
Role type
Senior Director, CMC Product Leader
Builds
Cell therapy products for Type 1 Diabetes
Domain
Biopharmaceutical Sciences - Cell & Gene Therapy
Required skills
CMC strategy development, cross-functional team leadership, process development, scale-up, technology transfer, GMP compliance, regulatory submission preparation, risk management, budgeting, project governance
Preferred skills
Cell therapy or regenerative medicine experience, advanced degree (PhD or MBA), experience leading major development programs at Director/Senior Director level, CMC regulatory submission experience
Technologies
GMP, CMC regulatory frameworks
Responsibilities
Develop and implement integrated CMC strategies; lead cross-functional CMC teams; partner with Program Teams for milestone delivery; oversee manufacturing process optimization; guide technology transfer and scale-up; develop CMC regulatory strategies; lead project approval processes; manage budgets and resources; mitigate technical and regulatory risks
Seniority
Senior Director, hands-on IC with strategic leadership
