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Associate Director, Drug Product Analytical Science and Technology
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Scorpion Therapeutics
Harvard, MA (In Person)
$186,816 Salary, Full-Time
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Job Description
Position Summary Leadership role responsible for technical oversight of the analytical method lifecycle within Cell Therapy Analytical Science and Technology. Leads a team of scientists providing analytical SME support to commercial Quality Control during investigations, method validation and transfers, regulatory submissions, and Health Authority interactions. Oversees operational workflows, metrics, and quality events (actions and investigations). Duties/Responsibilities Lead/manage analytical SMEs for commercial drug product release methods (cellular biology, molecular, flow cytometry). Provide technical oversight for method performance troubleshooting; evaluate analytical methods and data from internal/external labs, including OOS/OOT/aberrant result investigations. Oversee method performance metrics and completion of quality events (actions/investigations) in electronic systems. Serve as SME as needed. Partner with analytical development and commercial QC on optimization/automation to improve productivity and reduce testing cost. Interface with analytical development on method qualification strategies. Hire, mentor, and develop ASAT personnel. Qualifications Bachelor's degree in relevant scientific discipline (advanced degree preferred). 10+ years relevant experience (preferably GMP/regulatory; cellular therapy or gene therapy) and 2+ years in Analytical Science. 5+ years leadership experience. Experience with analytical method lifecycle (transfer, validation, maintenance). Quality Management knowledge (SOPs, Change Controls, Deviations, CAPAs, Risk Assessments, data integrity). Regulatory knowledge (FDA, EMA, ICH, USP, EP). Strong communication, mentoring/coaching, cross-functional collaboration; self-directed, detail-oriented. Travel to BMS/Partner sites required.