Director, Technical Operations

Role: Director, Technical Operations (Small Molecule CMC), overseeing API development and manufacturing activities at Travere Therapeutics. Responsibilities include providing technical oversight for API production, process scale-up, process validation, and technical documentation review; supporting GMP quality systems and regulatory submissions; and collaborating with cross-functional teams on product development, clinical supply, and lifecycle management. Requirements: Bachelor's in life sciences or related field, with 10+ years in small molecule API development and manufacturing, emphasizing late-stage clinical and commercial phases; extensive experience managing global CDMOs; deep knowledge of cGMP, US/EU/ICH guidelines; proven ability to author regulatory documents. Preferred skills include advanced degrees (MS, PhD), project management, and statistical expertise. HighValue: small molecule APIs, solid oral dosage forms, late-phase clinical development, CMC strategy, regulatory submissions (IND, NDA), global manufacturing oversight. WorkSetup: remote with 10-20% domestic/international travel; face-to-face collaboration required.