Associate Director, Technical Operations (Small Molecule CMC)

Role: Associate Director, Technical Operations (Small Molecule CMC) overseeing API development and manufacturing at Travere Therapeutics. Primary objectives include providing technical oversight for small molecule API scale-up, process characterization, process validation, and lifecycle management to support late-stage clinical development and commercialization. Responsibilities encompass reviewing manufacturing documentation, ensuring process qualification and validation at CDMOs, supporting GMP quality systems, authoring regulatory submissions (INDs, IMPDs, NDAs), and maintaining compliance with US and EU GMP and ICH guidelines. The role involves close collaboration with Quality, Regulatory, Clinical, and Supply Chain teams to align on project milestones, risk management, and product lifecycle activities. Requirements include a B.S. in chemistry, biochemistry, pharmaceutical sciences, or related, with 8+ years of experience in small molecule process development, scale-up, and commercial manufacturing, particularly for solid oral dosage forms. Preferred qualifications include an M.S. or Ph.D., experience managing global CDMOs, and knowledge of phase-appropriate cGMP, regulatory filings, and Six Sigma. High-value specifics involve late-stage clinical development, process validation, regulatory documentation, and international manufacturing oversight. The role is primarily remote with 10–20% domestic and international travel, based in San Diego, with face-to-face work expected.