Sr. Director External Manufacturing
Structure Therapeutics
August 24, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Responsibilities
- Lead and oversee outsourced manufacturing for drug substance, drug product, and packaging/labeling (late-stage development and commercial).
- Define and execute external manufacturing strategy for development, PPQ, commercialization, and lifecycle management.
- Provide end-to-end CDMO oversight; establish operating models, governance, and performance management.
- Select CDMOs for API and drug product; manage executive relationships; run business reviews; define/monitor KPIs; drive continuous improvement.
- Oversee tech transfer; ensure PPQ and CPV execution.
- Collaborate on commercial product launch readiness.
- Oversee CDMO production execution; partner on production planning, forecasting, order management, and inventory alignment.
- Lead technical oversight (API synthesis, spray-dried dispersions, tableting, bottling/packaging); investigate deviations/nonconformances; troubleshoot and implement root-cause fixes.
- Ensure global GMP compliance; support batch release, investigations, validation/CPV, deviation/CAPA, and regulatory inspection readiness.
- Coordinate logistics/material flow across sites; plan network capacity; mitigate supply risks (e.g., dual sourcing).
- Partner cross-functionally to ensure uninterrupted late-phase and commercial supply; support regulatory filings and launch planning/coordination with CDMOs.
Qualifications
- B.S. in Chemistry/Chemical Engineering (or related); M.S./Ph.D./MBA preferred.
- 15+ years pharmaceutical manufacturing experience managing external manufacturing/CDMOs.
- Deep small-molecule + oral solid dose (OSD) expertise; unit operations knowledge (API through packaging/labeling).
- Experience with late-stage development, PPQ, and commercial launches; CDMO selection/management.
- Strong GMP, validation, CPV, and quality systems knowledge; global CDMO network experience.
- Strong troubleshooting, leadership, communication, and cross-functional collaboration; works in fast-paced matrix/virtual settings.
Skills/Benefits (explicit)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application
- Apply via the official career page at BambooHR.
- Lead and oversee outsourced manufacturing for drug substance, drug product, and packaging/labeling (late-stage development and commercial).
- Define and execute external manufacturing strategy for development, PPQ, commercialization, and lifecycle management.
- Provide end-to-end CDMO oversight; establish operating models, governance, and performance management.
- Select CDMOs for API and drug product; manage executive relationships; run business reviews; define/monitor KPIs; drive continuous improvement.
- Oversee tech transfer; ensure PPQ and CPV execution.
- Collaborate on commercial product launch readiness.
- Oversee CDMO production execution; partner on production planning, forecasting, order management, and inventory alignment.
- Lead technical oversight (API synthesis, spray-dried dispersions, tableting, bottling/packaging); investigate deviations/nonconformances; troubleshoot and implement root-cause fixes.
- Ensure global GMP compliance; support batch release, investigations, validation/CPV, deviation/CAPA, and regulatory inspection readiness.
- Coordinate logistics/material flow across sites; plan network capacity; mitigate supply risks (e.g., dual sourcing).
- Partner cross-functionally to ensure uninterrupted late-phase and commercial supply; support regulatory filings and launch planning/coordination with CDMOs.
Qualifications
- B.S. in Chemistry/Chemical Engineering (or related); M.S./Ph.D./MBA preferred.
- 15+ years pharmaceutical manufacturing experience managing external manufacturing/CDMOs.
- Deep small-molecule + oral solid dose (OSD) expertise; unit operations knowledge (API through packaging/labeling).
- Experience with late-stage development, PPQ, and commercial launches; CDMO selection/management.
- Strong GMP, validation, CPV, and quality systems knowledge; global CDMO network experience.
- Strong troubleshooting, leadership, communication, and cross-functional collaboration; works in fast-paced matrix/virtual settings.
Skills/Benefits (explicit)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown).
Application
- Apply via the official career page at BambooHR.