CMC Project Leadership Director, Late-Stage Programs

Structure Therapeutics, Inc.; South San Francisco (CA); Hybrid; USD 209,000 - 260,000; Full time

Benefits offered by this job

medical

dental

vision insurance

401k match

unlimited PTO

paid holidays

Job summary

Structure Therapeutics Inc. in South San Francisco, CA, seeks a Director Technical (CMC) Project Management to lead end-to-end CMC programs from late-stage development through commercialization and lifecycle management.

You will drive integrated plans, budgets, risks, and cross-functional alignment for Tech Ops and CMC teams. The role requires 12+ years in pharma/biotech CMC, strong PM tool expertise, and experience with small molecule OSDS, commercialization, and lifecycle management.

Qualifications

• B.S. in Chemistry, Engineering, or related discipline required; advanced degree (M.S. or Ph.D.) and accreditation in Project Management preferred.
• 12+ years of progressive experience in pharmaceutical or biotech CMC functions, including one or more: manufacturing, process development, analytical, quality, supply chain, or regulatory CMC.
• At least 5+ years of experience in project management supporting late-stage development through commercial launch.
• Direct experience with small molecule and oral solid dosage (OSD) products.
• Demonstrated experience supporting commercialization and lifecycle management activities.
• Strong understanding of CMC development, manufacturing, regulatory and supply processes and requirements.
• Expertise in project management tools (e.g., MS Project, Smartsheet, Excel, PowerPoint).
• Strong experience developing and managing detailed project plans and timelines.
• Good understanding of financial planning, budgeting, and accrual tracking processes.
• Proven ability to operate effectively in a fast-paced, matrixed, and global environment.
• Strong analytical, problem-solving, and decision-making capabilities.
• Ability to think strategically while maintaining attention to detail and execution.
• Excellent communication and cross-functional influence.

Responsibilities

• Lead end-to-end CMC project management for late-stage development programs through commercial launch and lifecycle management.
• Develop and maintain integrated cross-functional project plans covering drug substance, drug product, analytical, quality, regulatory, and supply chain activities.
• Ensure alignment of project execution with overall program strategy, timelines, and business objectives.
• Serve as a key member of the Technical Operations leadership team.
• Develop and manage detailed project plans (Gantt-based) including timelines, milestones, dependencies, and critical paths.
• Track execution of activities across internal teams and CDMO partners across multiple time zones.
• Monitor progress against timelines, budgets, and deliverables; proactively identify and resolve risks and issues.
• Drive accountability for action items, deliverables, and project milestones.
• Facilitate weekly CMC team meetings and other governance forums.
• Develop proactive agendas and prepare supporting materials to drive effective decision-making.
• Establish and enforce best practices for meeting management, communication, and cross-functional information flow.
• Ensure clear documentation of decisions, actions, and follow-ups.
• Partner with Tech Ops department heads to develop project and multi-year departmental budgets.
• Collaborate with Finance and CDMOs to track spending, accruals, and budget performance.
• Ensure alignment between project plans, work orders, and financial forecasts.
• Provide regular financial and project status reporting to leadership.
• Interface with Tech Ops functional leads, including External Manufacturing, Process Development, Analytical, Quality, Regulatory CMC, and Supply Chain.
• Support department heads and working teams coordinate project activities across a network of global CDMOs.
• Partner with Procurement and Legal to ensure timely execution of work orders, contracts, and budget approvals.
• Interface with company-wide program teams and project managers to ensure consistent reporting of dashboards, progress, and risks.
• Develop and maintain project risk registers and mitigation strategies.
• Proactively manage project risks related to timelines, cost, quality, and supply.
• Identify and drive continuous improvement opportunities including timeline acceleration, cost optimization, and risk reduction.
• Ensure lessons learned are captured and implemented across programs.
• Establish best-in-class project management standards, tools, and processes within Technical Operations.
• Drive a culture of collaboration, accountability, innovation, and execution excellence.
• Serve as both a strategic leader and hands-on contributor in a growing organization.
• Mentor and develop project management capabilities across the organization.

Skills

MS Project

Smartsheet

Excel

PowerPoint

Project management

Cross-functional influence

Financial planning

Analytical thinking

Communication

Late-stage development

Small molecule

Education

B.S. in Chemistry, Engineering, or related discipline

M.S./Ph.D. and Project Management accreditation preferred

Tools

MS Project

Smartsheet

Excel

PowerPoint

Job description

Structure Therapeutics Inc. in South San Francisco, CA, seeks a Director Technical (CMC) Project Management to lead end-to-end CMC programs from late-stage development through commercialization and lifecycle management.

You will drive integrated plans, budgets, risks, and cross-functional alignment for Tech Ops and CMC teams. The role requires 12+ years in pharma/biotech CMC, strong PM tool expertise, and experience with small molecule OSDS, commercialization, and lifecycle management.