CMC Project Manager

Job Description

Duties and Responsibilities:

• Lead integrated CMC planning across Drug Substance, Drug Product, Analytical, Quality, Regulatory, and Supply Chain, aligning deliverables, timelines, and priorities with clinical and regulatory objectives.
• Drive execution of CMC plans to ensure alignment with program milestones and overall development timelines.
• Provide end-to-end project management support across the product lifecycle, from development through commercialization and commercial manufacturing.
• Develop, maintain, and manage integrated project timelines in Planisware or Smartsheet, clearly defining dependencies, milestones, and critical path activities.
• Facilitate cross-functional Product Team meetings, including agenda development, decision documentation, and action item tracking.
• Proactively identify, assess, and manage program risks and issues; maintain risk registers and ensure timely mitigation and corrective actions.
• Coordinate preparation of high-quality governance materials in collaboration with Product Teams.
• Translate complex technical input from subject matter experts into clear, actionable insights to support strategic decision-making.
• Ensure clear, timely communication of program status and key updates to all stakeholders.
• Partner with Product Teams and Finance on budget planning, tracking, and forecasting.
• Ensure compliance with established processes and practices; identify and share best practices across Product Teams and PMs.
• Integrating emerging AI and digital technologies into project management practices

Education and Experience:

• Minimum 5-8 years of relevant experience and a BA or BS in Life Sciences or related disciplines preferred.
• Relevant experience consists of cross-functional work in biopharmaceutical /pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs.
• Prior experience in project management required; PMP certification desirable.

Knowledge, Skills and Abilities:

• Solid understanding of project management methodologies, tools, and techniques (Planisware familiarity is a plus).
• Excellent organizational skills, capable of setting priorities and delivering on commitments.
• Strong interpersonal and communication skills.
• Demonstrated ability to collaborate closely with project leads, teams and scientific and business leadership.
• Strong leadership skills with the ability to motivate and inspire global cross-functional teams.
• Ability to manage complex situations and adapt to changing business needs.
• Proactive mindset.