Senior Director, Technical Operations

Role: Senior Director, Technical Operations (Small Molecule CMC), responsible for leading and executing technical strategy for small molecule API development and manufacturing at Travere. Objectives include overseeing API process development, scale-up, process characterization, validation, and technology transfer, ensuring compliance with GMP standards. Responsibilities involve providing technical oversight for manufacturing, reviewing documentation, managing CDMO relationships, and supporting regulatory submissions (INDs, NDAs). The role requires close collaboration with Quality, Regulatory, Clinical, and Supply Chain teams to meet project milestones across product lifecycle stages. Qualifications include a Bachelor's degree in Life Sciences or related fields, with 12+ years of experience in small molecule API development, late-stage clinical scaling, and commercialization; advanced degrees preferred. Expertise in process development, cGMP regulations, and managing global CDMOs is essential. High-value specifics: focus on solid oral dosage form, late-phase development, and regulatory documentation. The position involves 10-20% domestic and international travel, with onsite work in San Diego. The role demands strong leadership, project management, and cross-functional collaboration skills, aligned with core values of courage, community, patient focus, and teamwork.