Director, Drug Product Manufacturing

Description

The Director, 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.

• 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.

• PhD degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related discipline; advanced degree preferred.
• 15+ years of relevant pharmaceutical or biotechnology experience, with significant experience in drug product manufacturing and technical operations.
• Demonstrated experience supporting products through late-stage development, process validation, regulatory approval, and/or commercial launch.
• Strong experience managing outsourced manufacturing through CMOs/CDMOs.
• Demonstrated CMC regulatory experience, including preparation or review of drug product manufacturing content for regulatory submissions and support of health authority interactions.
• Direct experience working within a commercial pharmaceutical supply chain, including capacity planning, inventory, production planning, supply continuity, and launch readiness.
• Experience with technology transfer, scale-up, process characterization, and PPQ/process validation.
• Strong knowledge of cGMP requirements and commercial manufacturing expectations.
• Demonstrated ability to lead cross-functional initiatives, manage external partners, and communicate technical and supply risks to senior leadership.

• Experience with manufacturing of biologics and small molecule drugs considered a plus.
• Experience supporting an NDA/BLA/MAA through approval and commercial launch.
• Experience building manufacturing and supply capabilities within a pre-commercial or emerging commercial biotechnology company.
• Experience with commercial launch inventory, supply planning, and pre-approval inspections.
• Oncology and/or metabolic disease/obesity experience.

Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride…