Sr. Director, External Manufacturing

Structure Therapeutics; South San Francisco (CA); On-site; USD 240,000 - 360,000; Full time

Benefits offered by this job

Annual performance incentive bonus

New hire equity; ongoing performance‑基

Job summary

Structure Therapeutics Inc. in South San Francisco, CA, seeks a Sr. Director/Executive Director of External Manufacturing to lead outsourced manufacturing for drug substance, drug product, and packaging/labeling for late-stage and commercial programs.

You will provide strategic, technical, and operational direction and ensure end-to-end CDMO oversight for reliable, compliant supply. You will build a global CDMO network, manage governance and KPIs, drive tech transfer (PPQ/CPV), support launches,

Qualifications

• 15+ years pharmaceutical manufacturing experience
• Significant external manufacturing/global CDMO experience
• Deep small-molecule and OSD expertise
• Experience with late-stage development, PPQ, commercial launches
• GMP, validation, CPV, quality systems knowledge
• Strong troubleshooting and cross-functional leadership in matrix/virtual environments

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.

Skills

External manufacturing leadership

Cross-functional leadership

Troubleshooting

Matrix/virtual environments

Education

BS in Chemistry or Chemical Engineering (required)

MS/PhD/MBA preferred

Job description

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.