Associate Director, CMC Program Mgmt

Role: Lead CMC strategy and project management for biotherapeutic programs from research through commercialization, ensuring timely deliverables and regulatory submissions. Responsibilities: oversee CMC plans, manage CRO/CMO vendor relationships, facilitate internal project teams, maintain timelines and budgets, identify and communicate risks, and collaborate with technical and cross-functional teams to align development strategies. Requirements: BA/BS in Science, Mathematics, Engineering, or related field; 12+ years biotech/pharma/CMC experience (or 10+ with Master’s); strong CMC experience with novel constructs, GMP knowledge, and vendor management. Preferred: advanced degree, experience with bi-specifics or enzyme fusions. HighValue: biologics, drug substance and drug product GMP, late-stage development (Phases 2/3, NDA/MAA/BLA), CRO oversight, cross-functional collaboration. WorkSetup: not specified.