Associate Director, Technical Operations Quality Control

Role: Associate Director, Technical Operations QC, overseeing QC activities for small molecule drug products in rare disease development, ensuring GMP and regulatory compliance. Responsibilities: lead QC support for drug substance and product manufacturing, oversee specifications, batch release, and stability programs at CMOs; provide scientific support for testing, stability studies, method transfer, regulatory submissions, and process change assessments; manage investigations of OOS/OOT results and support vendor audits. Requirements: Bachelor's in Chemistry, Biochemistry, or related; 8+ years in analytical operations, development, or QC within biotech/pharma, with experience in biologics and small molecules; expertise in analytical methods such as HPLC, GC, MS, NMR; knowledge of GMP and regulatory standards (FDA, ICH, EU). Preferred: MS or higher degree, late-stage drug development experience, familiarity with Veeva. High-Value: rare disease focus, small molecule drugs, GMP environment, regulatory compliance, stability, and quality control leadership. Collaboration: work closely with Analytical, CMC, Regulatory, and Manufacturing teams. WorkSetup: Remote with 10-20% travel, face-to-face work in San Diego as needed.