Senior Principal Scientist, Drug Substance

Job Summary

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