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 Certificates of Analysis (CoAs).
• Assist in Out-of-Specification (OOS) and Out-of-Trend (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, and reference standard.
• Provide scientific and technical support to internal and external groups to ensure products are manufactured and released in compliance with all applicable regulations.
• Additional duties as assigned.

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.