Associate Director, Technical Operations (Analytical Development-Biologics)

Role: Associate Director of Technical Operations specializing in biologics analytical development, supporting the clinical to commercial phases for rare disease therapies. Responsibilities: oversee method development, validation, and transfer at CDMOs/CROs; manage specification setting, review validation protocols, SOPs, batch records, and CoAs; handle reference standards and investigations; contribute to regulatory submissions as a technical SME; provide scientific support to internal/external teams. Requirements: B.S. in chemistry, biochemistry, or related field; 8+ years in biologics analytical development, with expertise in HPLC, CE-SDS, cIEF, potency assays, peptide mapping, ELISA, LC-MS; experience with PEGylated or lyophilized biologics preferred. HighValue: biologics (likely late-stage development), analytical validation, regulatory compliance (FDA, ICH, EU), cGMP, cross-functional collaboration, international regulatory standards, 10-20% domestic/international travel. WorkSetup: remote with onsite requirements in San Diego, USA.