Associate Director, Technical Operations - Drug Product

Department: 106800 Technical Operations Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients. Position Summary: The Associate Director, Technical Operations - Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. The successful candidate enjoys managing external CDMOs and collaborating closely with colleagues in Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain. This position is a key CMC contributor for the clinical development through the commercialization of a small molecule drug product for a rare disease indication. Responsibilities: * Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of drug product manufacture of a small molecule, solid oral product at Travere's CDMOs. * Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports. * Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories. * Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections. * Collaborate on CMC development and commercialization of drug product with internal and external project teams. * Author and review technical documents and regulatory filings, including INDs, IMPDs, and NDAs. * Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production. * Review project scope and ensure that contractual obligations of CDMOs meet quality standards and timelines. * Provide technical recommendations to leadership regarding CDMO performance, process readiness, validation strategy, regulatory risks, and commercialization milestones. * Additional duties assigned as needed. Education/Experience Requirements: * Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or other related discipline required. Equivalent combination of education and applicable job experience may be considered. Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred. * 8+ years of relevant work experience including small molecule drug product manufacturing with a focus on scale-up, late phase clinical development, and commercialization. * Manufacturing experience with amorphous solid dispersions (spra y dried amorphous... For full info follow application link. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer