Senior Manager, Drug Product

Job description

The Opportunity: - You will be an integral part of Relay’s drug product development team supporting Relay's development programs. - You will be responsible for design and development of robust, scalable drug product formulation and manufacturing processes that ensure product quality and are commercially viable. - You will be overseeing technical activities at drug product CMOs, including technology transfer, clinical trial material (CTM) production, process troubleshooting, QbD and PAR studies, risk assessments, registration batch production, and process validation Your Role: - You will manage requisite formulation and process development (R&D) activities to support clinical development Relay pipeline programs. - You will be responsible for assessing and selecting appropriate packaging (container closure systems) for Relay’s development products. - You will design and develop robust R&D and GMP stability studies for investigational drug products in collaboration with internal AD/QC team and third parties. - You will contribute to completion (author/review) of relevant drug product sections of regulatory submission documents (IND, IMPD, NDA, briefing packages etc.), responses to reg...