Sr. Director External Manufacturing
Structure Therapeutics Inc.
Position Summary: Sr. Director/Executive Director of External Manufacturing (reporting to VP, Global Manufacturing & Supply Chain) provides strategic, technical, and operational leadership for outsourced manufacturing of drug substance, drug product, and packaging/labeling for late-stage development and commercial programs. Ensures end-to-end CDMO oversight for reliable, compliant, cost-effective supply of small-molecule APIs and oral solid dose (OSD) products. Responsibilities Build/lead CDMO network; define and execute external manufacturing strategy. Oversee CDMOs across drug substance and drug product; establish governance, operating models, and partner performance management. Select and manage CDMOs; run business reviews; define/monitor KPIs; drive continuous improvement. Oversee technology transfer; ensure PPQ and CPV execution; support commercial launch plans. Oversee CDMO production (API/OSD/packaging); support planning, forecasting, and order management. Provide unit-operation technical leadership (API synthesis, spray-dried dispersions, tableting, bottling/packaging); troubleshoot and resolve deviations/nonconformances/product complaints. Ensure global GMP/regulatory compliance; partner on batch release, investigations, validation, CPV, deviations, CAPA, and inspection readiness. Coordinate global logistics/material flow; plan capacity; mitigate supply risk; contribute to budgeting/forecasting. Lead/coordinate CDMO communication for new product launch; support regulatory filings and lifecycle management. Qualifications (Required/Preferred) BS in Chemistry/Chemical Engineering or related (required); MS/PhD/MBA preferred. 15+ years pharmaceutical manufacturing; significant external manufacturing/global CDMO experience. Deep small-molecule and OSD expertise; unit operations knowledge from API to packaging/labeling. Experience with late-stage development, PPQ, commercial launches; CDMO selection/management track record. GMP, validation, CPV, quality systems knowledge; global CDMO network experience. Strong troubleshooting, cross-functional leadership/communication, and ability in matrix/virtual environments. Travel: Up to 30% globally. Benefits Annual performance incentive bonus. New hire equity; ongoing performance-based equity. Medical/dental/vision. 401k match. Unlimited PTO. Paid holidays including winter shutdown. #J-18808-Ljbffr Structure Therapeutics Inc.
$200k - $250k
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