Senior Director/Director, CMC-Drug Product Manufacturing

The Senior Director/Director, CMC-Drug Product Manufacturing, leads drug product manufacturing activities, overseeing external manufacturing, technology transfer, fill-finish, formulation development, analytical development, testing for release and stability, process validation, commercial readiness, CMC regulatory support, and integration of drug product manufacturing into the broader commercial supply chain. This role will be based hybrid to Norwood, Ma.

Key Responsibilities

• Lead drug product manufacturing strategy and execution for clinical and commercial programs.
• Manage external CMOs/CDMOs, including technical oversight, performance management, capacity planning, and issue resolution.
• Lead technology transfer, scale-up, process characterization, PPQ/process validation, and commercial manufacturing readiness.
• Work with the CMC team to establish commercial manufacturing strategies, including capacity, inventory, production planning, launch supply, and business continuity.
• Ensure drug product manufacturing is effectively integrated with drug substance, packaging, labeling, distribution, and the broader end-to-end commercial supply chain.
• Partner with Regulatory to develop and review drug product manufacturing content for INDs/CTAs, NDAs/BLAs/MAAs, health authority responses, and other regulatory submissions.
• Support health authority interactions, inspections, and manufacturing-related regulatory strategy.
• Partner with Quality to ensure cGMP compliance, inspection readiness, and effective management of deviations, changes, and manufacturing risks.
• Identify and mitigate technical, regulatory, capacity, and supply risks ahead of commercialization.
• Represent Drug Product Manufacturing on cross-functional teams.
• Help build the processes, systems, external partnerships, and capabilities required as the company transitions from clinical development to commercial operations.