Associate Director, Chemical Development
Core
Lead cGMP manufacturing activities for drug substance scale-up from preclinical through commercialization, managing CMOs and regulatory submissions.
Role type
Associate Director, Chemical Development
Builds
cGMP drug substance for clinical and commercial programs
Domain
Pharmaceutical manufacturing / CMC
Required skills
cGMP manufacturing, process scale-up, CMO management, regulatory submissions (Module 3), QbD, process validation, supply chain logistics
Responsibilities
Scale candidate compounds to support drug discovery and clinical programs; Identify and manage CMOs for process optimization and cGMP manufacture; Implement process characterization and control strategies using QbD principles; Lead process validation programs for commercialization; Prepare and review CMC sections of regulatory submissions (INDs, NDAs, MAAs); Represent the company as DS expert before regulatory authorities.
Seniority
Senior, hands-on IC