Senior Principal Scientist, Drug Substance

Driving drug substance process development and manufacturing, the full-time remote Senior Principal Scientist, Drug Substance will lead end-to-end processes for small molecule APIs, manage CDMO partnerships, and ensure regulatory compliance while supporting the commercialization of innovative veterinary medicines. Key responsibilities Lead drug substance process development and manufacturing from early development through commercialization at CDMOs Serve as the primary technical interface with CDMOs, ensuring supply continuity and managing performance Author and review drug substance CMC sections for regulatory submissions and represent drug substance CMC in agency interactions Required qualifications Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related discipline 12+ years of industry experience in drug substance process development and manufacturing Hands-on expertise in small molecule API process development and impurity profiling Proven experience managing CDMOs and authoring drug substance CMC regulatory submissions Deep knowledge of applicable regulatory frameworks, including ICH guidelines relevant to veterinary drug substances