CMC Project Manager

Role Summary

CMC Project Manager based in Framingham, MA. The role contributes to the CMC Project Excellence department to deliver world class Sanofi CMC Project Management and enables efficient collaboration across CMC with a focus on timely project deliverables. The position covers CMC operational management of internal and collaboration project portfolios, and support for licensing, mergers & acquisitions, and operational excellence using PM standards, Lean and Agile tools.

Responsibilities

• Translate CMC strategy into operational plans and deliverables.
• Operationalize the CMC strategy for a project into a CMC planning with an optimal critical path.
• Develop CMC planning scenarios in collaboration with OPCM, the financial partner Demand & Supply Leader, and other SMEs.
• Assess feasibility and optimize the CMC operational plan with Functions representatives and communicate to the CMC team.
• Lead risk assessment and mitigation planning.
• Integrate the supply plan into the CMC operational plan and ensure alignment with strategy and overall project plan.
• Coordinate DS and DP delivery and release on time for internal and external production, in close coordination with Analytical and Quality representatives.
• Ensure execution, integration, and coordination of the CMC operational plan and monitor progress through operational meetings.
• Analyze and report on CMC operational plan execution, define the optimal plan for the critical path, and propose contingencies as needed.
• Contribute to project documents and governance meeting preparation (e.g., Technical Review, CMC Board, TARC, DWG, IDCC).
• Promote and implement Good Project Management practices.
• Support Business Development Licensing-in and -out projects, including due diligence and data room preparation where applicable.
• Support transversal initiatives contributing to simplification and harmonization within the Project Excellence global team.

Qualifications

• Required: Bachelor's degree in sciences or engineering (Biotechnology, Chemistry, Gene Therapy, Microbiology, etc.) with at least 7+ years of relevant pharmaceutical experience.
• Preferred: PhD or MSc (PharmaD) degree.
• Past experience in project management.
• Experience managing international, multidisciplinary, and/or multicultural teams.

Skills

• Excellent knowledge in CMC development, R&D and Industrial interfaces.
• Excellent project management skills.
• Strong English oral and written communication.
• Ability to lead transversely a multidisciplinary and multicultural team.
• Excellent negotiation skills.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint), MS365, flow diagramming, MS Project, and Thinkcell.

Education

• Bachelor's degree in sciences or engineering (Biotechnology, Chemistry, Gene Therapy, Microbiology, etc.).
• PhD or MSc (PharmaD) preferred.