As a Senior CMC Global Project Manager, you will lead cross-functional CMC subteams to develop and execute strategic CMC roadmaps across assets. You’ll partner with the CMC Lead and Asset Operations Lead to drive integrated plans, budgets, and governance, ensuring timely, on-budget delivery. You’ll mentor teams, manage risk, and enable effective communication with senior stakeholders. This role sits at the heart of Ipsen’s Asset Team to maximize patient value and streamline development programs.
Responsibilities
Serve as the central operational point for CMC, subteams, and Asset Team members
Create and maintain asset CMC roadmap aligned with asset strategy
Develop and maintain CMC project plans with interdependencies across functions
Lead cross-functional monthly CMC operations meetings and monitor execution
Manage budgets, resources, and governance communications; escalate issues with mitigation plans
Apply consistent risk management and identify contingencies for project delivery
Support vendor selection and management as needed
Ensure compliance with GxP, regulatory requirements, and quality systems
Capture lessons learned and benchmark against competitors to drive improvement
Provide leadership, mentorship, and cross-functional collaboration across regulatory, manufacturing, formulation, analytics, quality, and supply
Key requirements
8-10+ years in Pharmaceutical/Biotech with CMC development experience
Demonstrated leadership of cross-functional drug development operations
Strong budgeting, resource forecasting, and cost control abilities
Excellent communication, stakeholder management, and negotiation skills
Proficiency in cross-functional project leadership in fast-paced environments
Knowledge of regulatory submissions and compliance knowledge (preferred)
Experience with project management tools and data-driven decision making
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