Manager, CMC Project Management

Manager, CMC Project Management

This role will partner with CMC Technical Leads to drive the planning, coordination, and execution of complex CMC development programs across the Technical Operations and Quality (TOQ) organization. The role serves as the operational leader for assigned projects, developing and maintaining integrated project plans, managing risks and dependencies, driving cross-functional alignment, and ensuring timely delivery of program objectives. The successful candidate is a proactive, self-motivated project manager with strong organizational, communication, and problem-solving skills who leverages project management tools, metrics, and best practices to enable quality decision-making, improve team effectiveness, and support successful project outcomes.

This position is hybrid and will be primarily located in Cambridge, MA at our Kendall Square location.

Key Responsibilities:

• Lead day-to-day project management and execution for multiple CMC development programs, ensuring alignment across internal functions and external partners
• Develop, maintain, and drive integrated project plans that capture key activities, milestones, deliverables, dependencies, resource requirements, and critical paths
• Coordinate and manage cross-functional execution with CMC Technical Leads across Manufacturing, Process Sciences, Analytical Science, Supply Chain, Quality, Regulatory Affairs, and external partners, ensuring timely completion of project deliverables
• Proactively identify project risks, issues, assumptions, and dependencies; facilitate mitigation planning, issue resolution, and escalation of critical decisions as needed
• Facilitate effective cross-functional team meetings, driving accountability through clear action-item tracking, decision documentation, follow-up, and communication of outcomes.
• Build strong partnerships and influence stakeholders across disciplines to align priorities, resolve competing needs, and achieve program objectives
• Utilize project management tools and systems to maintain project visibility, support decision-making, track performance metrics, and communicate program status
• Drive continuous improvement of project management processes, tools, templates, and team operating practices to enhance efficiency, consistency, and execution excellence across the organization

Qualifications:

• Bachelor's degree or equivalent working experience preferred. Minimum 5 years of direct project management experience in the biotechnology, pharmaceutical, or related industry.
• Experience supporting CMC development programs (preclinical through commercial readiness) strongly preferred.
• Demonstrated success managing complex, cross-functional projects involving multiple stakeholders, competing priorities, and evolving timelines
• Strong analytical, organizational, and problem-solving skills with the ability to connect operational details to broader program objectives
• Excellent interpersonal, communication, facilitation, and presentation skills
• Experience utilizing project management tools and systems such as Smartsheet, Planisware, Microsoft Project, or equivalent platform
• Demonstrated commitment to continuous improvement through the application of project management best practices, process improvements, and operational excellence initiatives

U.S. Pay Range $ - $