Director, Technical (CMC) Project Management

Position Summary

Reporting to SVP Technical Operations, the Director Technical (CMC) Project Management will provide technical CMC project management support and leadership across all late-stage development programs through commercialization and lifecycle management.

Job Responsibilities

• Strategic CMC Project Leadership
  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.

• Project Planning, Tracking and Execution
  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.

• Team Facilitation and Meeting Management
  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.

• Budgeting, Financial Tracking & Reporting
  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.

• Cross-Functional & External Coordination
  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.

• Risk Management & Continuous Improvement
  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.

• Project Management Excellence
  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.

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 of the following: 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.