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Director, Quality Analytical Technical Lead, Small Molecule

beigene·US·United States·senior
rest
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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Analytical Technical Lead (ATL) is the single global point of contact and accountable owner for analytical lifecycle management of assigned commercial products across major markets (US, EU, China, Australia, Canada) and supports Rest of World (RoW) expansion and post-approval maintenance. At Director level, this role is responsible for making risk-based, inspection-defensible decisions on methods, specifications, stability, and analytical investigations across a distributed internal/external QC network for small molecule products. This leader ensures the analytical control strategy remains robust over the product lifecycle, drives harmonization, and enables reliable supply while meeting GMP, pharmacopeial, and regulatory expectations. The Analytical Technical Lead (ATL) may own relevant global business processes, ensure compliance and efficiency. Essential Functions of the Job: A. Global Analytical Point of Contact (PoC) for Approved Commercial Products Act as the global PoC for all analytical-related matters for assigned products, to ensure analytical readiness. Provide governance and technical leadership for analytical topics spanning drug substance (DS), drug product (DP), and critical raw materials/reagents as applicable. Translate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST. B. Analytical Lifecycle Management: Changes, Deviations, and Investigations Lead and approve strategy for analytical investigations and performance issues (OOS/OOT/OOE, atypical results, invalidations), ensuring scientifically sound root cause analysis and effective CAPA, including me

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