Director, Drug Product SME
Core
Lead CMC development for siRNA/oligonucleotide and small molecule drug products, ensuring formulation, process development, and clinical supply readiness from preclinical through commercialization.
Role type
Director, Drug Product SME (CMC)
Builds
Preclinical and clinical drug product formulations, processes, and clinical supply for MASH therapeutics
Domain
Biopharmaceuticals / siRNA and small molecule drug development
Required skills
siRNA/oligonucleotide formulation, small molecule formulation, CDMO oversight, cGMP compliance, regulatory document authoring, Quality-by-Design, statistical design of experiments, process validation, cross-functional leadership
Preferred skills
Acquisition integration, commercial manufacturing transition, regulatory agency interactions
Technologies
cGMP, ICH guidelines, eCTD, AI-enabled tools
Responsibilities
Lead pre-formulation data packages and development strategies; oversee CDMO relationships and technical documentation; author Module 3 eCTD content and regulatory submissions; implement Quality Risk Management; manage project budgets and operational excellence initiatives
Seniority
Director, strategic leadership with hands-on technical oversight
