Associate Director Drug Product SME
Core
Lead CMC development for small molecule drug products, focusing on formulation, process development, and clinical supply manufacture for MASH therapeutics.
Role type
Senior IC drug product SME (CMC)
Builds
Phase-appropriate quality investigational medicinal products and clinical supply
Domain
Biopharmaceuticals / Small molecule drug development
Required skills
Small molecule formulation, Process development, CDMO/CRO oversight, cGMP/ICH guidelines, Quality-by-Design, Statistical design of experiments, Regulatory document authoring, Cross-functional leadership
Preferred skills
Post-acquisition asset mobilization, Clinical to commercial manufacturing transition, Regulatory agency interactions
Technologies
AI-enabled tools, Statistical design of experiment practices
Responsibilities
Lead pre-formulation data packages and asset profiles, Optimize small-molecule formulations and processes, Oversee CDMO deliverables and troubleshoot drug product issues, Implement Quality Risk Management principles, Author CMC regulatory documents and quality reports
Seniority
Senior, hands-on IC
