Director, Technical Operations

Role: Director, Technical Operations (Small Molecule CMC) oversees API development and manufacturing for small molecule drug products, supporting clinical, commercial, and lifecycle stages. Responsibilities include providing technical oversight of API scale-up, process characterization, validation, and tech transfer, reviewing manufacturing documentation, managing deviations and CAPAs, and authoring regulatory submissions such as INDs, IMPDs, and NDAs. The role requires collaboration with Quality, Regulatory, Clinical, and Supply Chain teams to meet program milestones while ensuring compliance with GMP, ICH, and other regulatory standards. Qualifications: Bachelor's degree in Life Sciences, Chemistry, or related field; 10+ years of small molecule API development/manufacturing experience, particularly in late-stage clinical development and commercialization; extensive knowledge of cGMP and global regulatory requirements; proven experience managing CDMOs and third-party labs. Preferred: advanced degrees (MS/PhD), Six Sigma knowledge, and strong project management skills. HighValue: focus on small molecule solid oral dosage forms, late-phase development support, cGMP compliance, and global regulatory submissions. WorkSetup: remote with 10-20% travel, primarily based in San Diego, with face-to-face work essential.