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Alpha-9 Oncology, a clinical-stage biotechnology company focused on radiopharmaceutical innovation for solid tumors, is seeking an Associate Director of Analytical Development & Quality Control. This leadership role will oversee quality control activities across multiple clinical-stage radiopharmaceutical development programs, serving as the primary QC representative and technical leader.
Key responsibilities include: leading QC data review, trending, and lifecycle monitoring to support product quality and program progression; managing technical relationships with external CDMOs, contract laboratories, and suppliers; supporting batch release activities through analytical result review and quality event resolution; partnering with Quality Assurance and CDMO partners on deviation resolution, investigations, CAPAs, and other quality events; collaborating with Technical Operations, Regulatory, Supply Chain, and Program Management teams on clinical supply readiness; supporting analytical method development and qualification; providing technical oversight for raw material, precursor, API, and drug product development; authoring and reviewing technical reports, specifications, and CMC documentation; and monitoring external partner performance to identify and resolve technical, quality, and operational risks.
Required qualifications: Ph.D. in Analytical Chemistry, Chemistry, Radiochemistry, or related discipline with 8+ years of progressive pharmaceutical/biotech experience (or M.S. with 11+ years); at least 5 years managing external CDMOs, contract testing labs, or GMP manufacturing; demonstrated success managing multiple external partners across complex development programs; experience reviewing and interpreting analytical data for product quality and batch release; experience leading technical investigations, OOS/OOT assessments, deviations, and CAPAs; strong understanding of analytical method qualification, validation, and lifecycle management; knowledge of cGMP, ICH, and global regulatory requirements; strong communication skills; and ability to travel up to 25% domestically and internationally.
