Associate Director, Drug Product

Your Role:

• You will be the lead and an integral part of Relay’s drug product development team supporting development programs.
• You will be responsible for design, development and optimization of patient-centric (e.g. pediatric) drug product formulation and clinical / commercially viable manufacturing process including selection appropriate packaging (container closure systems) for Relay’s pipeline products.
• You will be leading and managing the outsourcing (formulation / product development and manufacturing) activities at global CRO/CMO sites, in alignment with program goals.
• You will manage prototype development/feasibility assessment and clinical manufacturing activities.
• You will support current and/or plan formulation / drug product R&D and GMP stability studies in collaboration with internal AD/QC, QA teams and third parties.
• You will be a key drug product SME for successful execution of the technology transfer of drug product processes to manufacturing site(s), providing technical in-puts / insights to the Relay’s CMOs.
• You will draft, review and approve specifications, batch records and other critical development and GMP documents.
• You will author, review and ensure completion of drug product sections of CMC-regulatory submission documents (IND, IM