Associate Director, Technical Operations (Analytical Development-Biologics)

Role: Associate Director, Technical Operations, specializing in analytical development for biologics in a rare disease biopharma setting. Primary objectives include leading method development, validation, transfer, and specification setting at CDMOs/CROs, ensuring compliance with cGMP, FDA, ICH, and EU standards. Responsibilities encompass authoring validation protocols, managing reference standards, reviewing batch records and CoAs, supporting root cause investigations, and contributing to regulatory submissions. Requirements: B.S. in chemistry, biochemistry, or related field; 8+ years in biologics analytical development, with hands-on experience in HPLC, CE-SDS, cIEF, bioassays, LC-MS, and familiarity with PEGylated or lyophilized products. Preferred skills include strong project management, knowledge of global GMPs, and effective cross-functional collaboration. HighValue: biologics, late-stage drug development, regulatory compliance, process transfer, and analytical method validation. WorkSetup: remote with 10-20% domestic/international travel.