Director, Technical Operations

Position Summary The Director, Technical Operations (Small Molecule CMC) provides technical oversight for small molecule API development and manufacturing activities at Travere CDMOs. Collaborates with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk management, and achievement of program milestones. Responsibilities Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule solid oral drug product. Review and approve manufacturing‑related documentation (change notifications, batch records, process development, tech transfer, process characterization, validation protocols/reports). Verify suitability, qualification, and validation status of processes at CDMOs and external laboratories. Support GMP quality management systems (deviations, investigations, CAPAs, change controls, regulatory submissions, facility inspections). Collaborate with internal/external teams to support CMC development, clinical supply, commercialization, and lifecycle management. Author/review technical documents and regulatory submission content (INDs, IMPDs, NDAs). Maintain knowledge of US/EU GMP, ICH guidelines, and regulatory expectations. Review project scope, timelines, and deliverables to meet contractual, quality, and program objectives. Education/Experience Requirements Bachelor’s degree (Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related). M.S./Ph.D. preferred. 10+ years’ experience in small molecule API development/manufacturing with late‑phase clinical development, scale‑up, and commercialization. Expert CMC knowledge from process development through PPQ, commercialization, and tech transfer for solid oral dosage forms. Experience managing global CDMOs, third‑party manufacturers, and testing labs. Phase‑appropriate cGMP and US/EU/ICH guideline knowledge. Additional Skills/Experience Strong communication and organizational skills; decision‑making and collaboration with attention to detail. Record of managing complex project plans/timelines/budgets and risk mitigation. Ability to travel 10–20% domestically/internationally; not 100% remote. Benefits Premium health, financial, work‑life/well‑being offerings, wellness/support programs, life insurance, disability, retirement with match, and generous paid time off. Target base pay range: $189,000–$246,000. Application Instructions Travere will accept applications on an ongoing basis until a candidate is selected. #J-18808-Ljbffr Scorpion Therapeutics