Associate Director, CMC Project Management

Associate Director, CMC Project Management

In this highly visible Technical Operations role, you will lead cross-functional planning and execution across development programs, driving CMC strategy, timelines, and manufacturing activities in partnership with external manufacturing organizations. Working closely with CMC, Quality, Regulatory, Clinical Supply, and Program Management teams, you will enable key development milestones, support regulatory submissions, and advance programs through the drug development lifecycle.

Key Responsibilities

• Provide end-to-end CMC project management support across all stages of development.
• Lead cross-functional teams across Chemical Development, Pharmaceutical Development, Analytical Development, Quality, Regulatory CMC, and Clinical Supply Chain to execute program objectives.
• Serve as the primary liaison for CMOs, facilitating meetings, managing deliverables, and driving action-item follow-through.
• Own program-level risk management, including risk identification, mitigation planning, issue escalation, and resolution.
• Partner with Program Management to align CMC activities, manage interdependencies, and maintain visibility into scope, timelines, and risks.
• Prepare analyses, recommendations, and governance materials to support leadership decision-making and resolve cross-functional challenges.
• Support planning and execution of regulatory submissions, including INDs, IMPDs, and other global filings.
• Drive effective communication through project plans, dashboards, status reports, and stakeholder updates.
• Foster strong partnerships across internal teams and external vendors to ensure successful execution.
• Champion continuous improvement of project management processes, governance, budgeting, and forecasting practices.

Qualifications

• Bachelor's degree in life sciences, engineering, scientific, technical, or business discipline (or equivalent experience); advanced degree preferred.
• 10+ years of professional experience, including at least 5 years in project management within the pharmaceutical, biotechnology, or medical device industry.
• 3+ years leading cross-functional teams in a matrixed environment, with demonstrated success delivering complex programs.
• Working knowledge of CMC functions, including process development, analytical development, formulation, manufacturing, quality systems, supply chain, packaging, and regulatory CMC requirements.
• Understanding of the drug development lifecycle from Pre-IND through NDA/commercialization; experience supporting late-stage or commercial programs is a plus.
• Familiarity with GMP/GxP environments and quality management systems, ideally for small molecule development.
• Proficiency with project management and collaboration tools (e.g., Smartsheet, Microsoft Project, SharePoint, Microsoft Office); PMP certification preferred.
• Strong organizational, prioritization, and time-management skills with the ability to manage multiple priorities in a dynamic environment.
• Excellent communication, stakeholder management, and influencing skills, with the ability to drive alignment without formal authority.
• Ability to work independently and collaboratively in fast-paced settings; start-up or growth-stage biotech experience preferred.
• Authorization to work in the United States required.