Associate Director, Technical Operations (Small Molecule CMC)

Role: Associate Director, Technical Operations (Small Molecule CMC), overseeing API development and manufacturing at Travere's CDMOs to support late-stage clinical and commercial small molecule drug products. Responsibilities: provide technical oversight of API production, process scale-up, characterization, validation, and process performance; review and approve manufacturing documentation and ensure regulatory compliance; support GMP quality systems, deviations, and inspections; collaborate with cross-functional teams on CMC development, clinical supply, and lifecycle management; author and review regulatory documents including INDs and NDAs; maintain knowledge of GMP and ICH guidelines. Requirements: B.S. in chemistry, biochemistry, pharmaceutical sciences, or related field; 8+ years of experience in small molecule API development, scale-up, and commercialization; proven experience managing CDMOs and regulatory filings. Preferred: advanced degrees (M.S./Ph.D.); knowledge of Phase 3 and commercial manufacturing; experience with US/EU GMP standards, statistical tools, and risk management. High-Value: small molecule APIs, solid oral dosage forms, late-stage clinical development, IND/NDAs, cGMP compliance, global manufacturing oversight. WorkSetup: remote with 10-20% travel, based in San Diego.