Director, Technical (CMC) Project Management
Structure Therapeutics
7 hours ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
Reporting to SVP Technical Operations, the Director Technical (CMC) Project Management provides technical CMC project management leadership across late-stage development through commercialization and lifecycle management.
Job Responsibilities
- Lead end-to-end CMC project management through commercial launch and lifecycle management.
- Develop and maintain integrated cross-functional plans across drug substance/product, analytical, quality, regulatory, and supply chain.
- Drive aligned execution to timelines and business objectives; member of Tech Ops leadership.
- Create and manage Gantt-based plans (milestones, dependencies, critical paths); track progress across internal teams and global CDMO partners.
- Monitor timelines, budgets, and deliverables; proactively manage risks/issues and drive accountability.
- Facilitate weekly CMC meetings/governance; develop agendas/materials; document decisions/actions.
- Partner on project and multi-year budgets; track spending/accruals with Finance/CDMOs; provide status reporting.
- Coordinate cross-functionally with External Manufacturing, Process Development, Analytical, Quality, Regulatory CMC, Supply Chain, Procurement, and Legal.
- Maintain risk registers; drive continuous improvement; capture lessons learned.
Qualifications
- B.S. in Chemistry/Engineering (required); M.S./Ph.D. and project management accreditation preferred.
- 12+ years in pharmaceutical/biotech CMC (manufacturing, process development, analytical, quality, supply chain, and/or regulatory CMC).
- 5+ years project management for late-stage development through commercial launch.
- Small molecule and oral solid dosage (OSD) experience.
- Strong CMC, manufacturing, regulatory, and supply understanding.
- Tools: MS Project, Smartsheet, Excel, PowerPoint; detailed plan/timeline management; budgeting/accrual tracking.
- Works effectively in fast-paced, matrixed global environments; strong analytical, communication, and cross-functional influence.
Required Travel: up to 25% globally.
Benefits (as stated)
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.
Reporting to SVP Technical Operations, the Director Technical (CMC) Project Management provides technical CMC project management leadership across late-stage development through commercialization and lifecycle management.
Job Responsibilities
- Lead end-to-end CMC project management through commercial launch and lifecycle management.
- Develop and maintain integrated cross-functional plans across drug substance/product, analytical, quality, regulatory, and supply chain.
- Drive aligned execution to timelines and business objectives; member of Tech Ops leadership.
- Create and manage Gantt-based plans (milestones, dependencies, critical paths); track progress across internal teams and global CDMO partners.
- Monitor timelines, budgets, and deliverables; proactively manage risks/issues and drive accountability.
- Facilitate weekly CMC meetings/governance; develop agendas/materials; document decisions/actions.
- Partner on project and multi-year budgets; track spending/accruals with Finance/CDMOs; provide status reporting.
- Coordinate cross-functionally with External Manufacturing, Process Development, Analytical, Quality, Regulatory CMC, Supply Chain, Procurement, and Legal.
- Maintain risk registers; drive continuous improvement; capture lessons learned.
Qualifications
- B.S. in Chemistry/Engineering (required); M.S./Ph.D. and project management accreditation preferred.
- 12+ years in pharmaceutical/biotech CMC (manufacturing, process development, analytical, quality, supply chain, and/or regulatory CMC).
- 5+ years project management for late-stage development through commercial launch.
- Small molecule and oral solid dosage (OSD) experience.
- Strong CMC, manufacturing, regulatory, and supply understanding.
- Tools: MS Project, Smartsheet, Excel, PowerPoint; detailed plan/timeline management; budgeting/accrual tracking.
- Works effectively in fast-paced, matrixed global environments; strong analytical, communication, and cross-functional influence.
Required Travel: up to 25% globally.
Benefits (as stated)
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.