Director, Quality Control Chemistry & Raw Materials

Role: Lead strategic and operational management of analytical chemistry testing for raw materials, in-process samples, and biologics at the Wilmington Biotech Campus, with a focus on high potent biologics including ADCs. Objectives include establishing laboratory startup, ensuring cGMP compliance, and supporting global regulatory activities. Responsibilities encompass laboratory design, validation, method transfer, raw material and in-process testing, investigation of OOS/OOT events, and team leadership. Qualifications: Bachelor's in biochemistry or chemistry (Master's or PhD preferred), 12+ years in biotech/pharma with expertise in separations, method validation, and raw materials testing, including experience with ADCs. Skills: Strong knowledge of regulatory standards (ICH, USP), lab automation, and leadership; proven experience with regulatory inspections. High-Value: biologics, ADCs, high potent compounds, cGMP, analytical lifecycle management, regulatory support, site start-up, leading a team of 20-30 FTE, travel ~25%. Work setup: Wilmington, Delaware, with international collaboration.