CMC Asset Lead, Associate Director

Role: Associate Director, CMC Asset Lead within PO&T, responsible for end-to-end asset leadership of clinical immunology programs, including strategy, development, supply, and lifecycle planning. Responsibilities: serve as asset owner, develop 5-year strategy and 18-month tactical plans, lead cross-functional teams (process development, manufacturing, quality, supply chain, regulatory), act as liaison between R&D and PO&T, manage risks and budgets, and develop business cases for key initiatives. Requirements: PhD (preferred) or equivalent in a biopharma discipline, 8+ years in CMC drug development or manufacturing, with experience in biologics or pharmaceuticals from research through clinical phases (IND to NDA/BLA). Proven matrix leadership, strategic planning, and risk management skills, with strong communication and stakeholder engagement abilities. HighValue: biologics, immunology, clinical development stage, CMC, cross-functional leadership, risk mitigation, strategic planning, hybrid work in Cambridge, MA.