Associate Director, Drug Product Technical Services (DPTS)

Role: Associate Director of DPTS overseeing drug product validation for Wave's injectable assets in Phase 1-3 trials, including formulation support, tech transfer, and regulatory documentation. Responsibilities: plan and execute DP formulation studies, oversee GMP manufacturing and tech transfer at CMO sites, author regulatory submission sections, manage CMO relationships, and ensure supply for clinical trials. Requirements: Ph.D. or equivalent in Pharmaceutical Sciences, Chemistry, or Engineering; 8+ years in biopharma GMP environment with PPQ experience; experience in DP formulation development, regulatory submissions, and managing CMO collaborations. HighValue: biologics/oligonucleotides, injectable drug products, Phase 1-3 clinical development, GMP compliance, and regulatory documentation expertise. WorkSetup: not specified; travel requirements not detailed.