Associate Director, Technical Operations (Analytical Development-Biologics

Responsibilities

• 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.

• 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.