Sr. Director External Manufacturing
Structure Therapeutics
8 hours ago
Remote friendly (South San Francisco, CA)
United States
Operations
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.
Application instructions: Apply through the official career page at BambooHR.
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.
Application instructions: Apply through the official career page at BambooHR.