Senior Director, Technical Operations

Role: Senior Director, Technical Operations (Small Molecule CMC) at Travere Therapeutics, leading strategy and oversight for small molecule API development and manufacturing. Responsibilities: provide technical leadership for API scale-up, process characterization, PPQ, and manufacturing at CDMOs; evaluate technical, regulatory, quality, and supply tradeoffs; author and review regulatory and manufacturing documentation; ensure GMP compliance; maintain knowledge of GMP and ICH guidelines; collaborate with Quality, Regulatory, Clinical, and Supply Chain teams to meet project milestones; advise senior leadership on technical decisions impacting late-stage development, clinical supply, and commercialization. Requirements: Bachelor's in Life Sciences, Chemistry, or related field; 12+ years in small molecule API development, manufacturing, and late-phase clinical support; extensive experience managing global CDMOs, process development, and regulatory filings (INDs, NDAs); deep knowledge of cGMP, US/EU regulations, and process validation. Preferred: advanced degrees (M.S., Ph.D.), Six Sigma knowledge, strong project management skills. High-Value: late-stage development and commercialization of solid oral small molecule drugs, global regulatory compliance, technical leadership in GMP environments, international travel (10-20%). Work setup: primarily remote with face-to-face work in San Diego as needed.