Associate Director, Technical Operations Quality Control

Role: Associate Director of Technical Operations Quality Control, overseeing QC activities for a small molecule drug in rare disease development. Responsibilities include managing QC support for drug substance and product manufacturing, overseeing stability programs, supporting method transfer, and ensuring compliance with GMP and international regulations. The role involves collaboration with Analytical, CMC, Regulatory, and manufacturing teams, including vendor oversight and support for regulatory submissions and process changes. Qualifications: Bachelor's in Chemistry, Biochemistry, or related field; 8+ years in analytical operations, development, or QC within biotech/pharma, preferably in late-stage drug development. Skills include expertise in analytical methods such as HPLC, GC, MS, NMR, IR, UV, and GMP/regulatory knowledge. Preferred: experience with biologics or small molecules, Veeva, and international travel up to 20%. The position is remote with some onsite requirements in San Diego, with a focus on rare disease therapeutics in clinical and preclinical phases.