Associate Director, Drug Product
Spyre Therapeutics · US
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for...
Job description
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Associate Director, Drug Product is a key leadership role responsible for overseeing technical operations related to drug product (DP) formulation, development, and manufacturing. This position requires close collaboration with cross-functional teams, including CMC, supply chain, clinical operations, regulatory, quality, and senior management. This role will lead the development of protein drug product processes and associated technical presentations, oversee technology transfer to CDMOs, and ensure the reliable delivery of high-quality DP supplies to support clinical trials. The ideal candidate brings deep expertise in process development, aseptic manufacturing (including prefilled syringes), combination product development, and GMP compliance. As a subject matter expert (SME) in DP manufacturing within the CMC organization, this individual will p...