Associate Director, Technical Operations

Role: Lead CMC development and manufacturing oversight for small molecule programs across Phase I–III, ensuring timely, compliant production of test articles and study drugs. Responsibilities: provide strategic leadership for process transfer, scale-up, validation, and cGMP manufacturing; manage external CMOs and technical partners; review regulatory submissions and batch documentation; oversee chemical development and manufacturing controls; support regulatory inspections and compliance; mentor project teams and authorship of CMC sections. Requirements: Bachelor's in Process/Chemical Engineering or related field; 8+ years in cGMP drug development or manufacturing, with leadership experience in small molecules, peptides, or biologics; strong knowledge of process validation, technology transfer, manufacturing controls, and regulatory standards; experience with oral solid dosage forms preferred. HighValue: small molecules, Phase I–III, cGMP manufacturing, regulatory documentation, external partner management, travel (~10%), primarily remote with onsite requirements in San Diego.