Associate Director, Technical Operations (Analytical Development-Biologics)

Reference: 629726Posted: 2026-07-30Location: San Diego, CaliforniaCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io:Manage and oversee method development, validation, and transfer for biologics products at CDMOs/CROs.Oversee specification setting of drug substance and drug product at CDMOs/CROs.Author/review analytical method validation protocol/report, method transfer protocol/report and SOPs.Manage reference standard program for drug substance and drug product.Review controlled documents such as batch records and CoAs.Assist in OOS and OOT investigations. Perform root cause analyses and recommend corrective actions.Contribute and act as the technical subject matter expert in preparation of regulatory submissions related to drug substance and drug product analytical package, characterization, reference standard.Provide scientific and technical support to internal and external groups to ensure that products are manufactured and released in compliance with all applicable regulations. Additional duties assigned as needed.Education/Experience Requirements: B.S. degree in chemistry, biochemistry, pharmaceutical science, or related Life Sciences discipline required. M.S. degree preferred. Equivalent combination of education and applicable job experience may be considered.8+ years of relevant experience in analytical development of biologics, preferably in late-stage drug development.Direct knowledge of HPLC, CE-SDS, cIEF, potency bioassays, peptide map, ELISA, LC-MS and other relevant analytical methods. Experience with PEGylated and/or lyophilized products is a plus.Extensive analytical development, validation and transfer background with experience reviewing analytical data and managing analytical development activities at external CDMOs/CROs.