CMC Project Manager

Job Title:

CMC Project Manager

Framingham, MA

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

The CMC Project Manager is a key contributor of the CMC Project Excellence department to provide a world class performance of Sanofi CMC Project Management.

The CMC Project Manager enables the most efficient transversal collaboration within and outside of CMC, fostering and aligning efficient ways of working, providing the relevant expertise and adding value by creating synergies across CMC entities and platforms through fundamental excellence in Project Management expertise. To ensure projects deliverable are met on time.

The role is covering the following CMC scope:

• CMC Project Operational Management of internal and collaboration project portfolio
• CMC Business Development Licensing and Merge & Acquisition support
• CMC Operational Excellence (PM standards, Lean and Agile project management tools applied to asset ) support

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

• Responsible for translating CMC strategy in operational plan & deliverables
• Operationalize the CMC strategy for a given project into a CMC planning, with optimal critical path
• Develop CMC planning scenario in close connection with OPCM, financial business partner Demand & Supply Leader and other SMEs in the project team
• Ensure CMC operational plan feasibility and optimization with Functions representatives and communicate to CMC team
• Lead risks assessment & mitigation plan
• Integrate supply plan and ensure delivery
• Integrate supply plan as part of the CMC operational plan and ensure alignment with CMC strategy and overall project plan
• Coordinate DS and DP delivery and release on time (for internal and external production), for critical batches, in close coordination with Analytical and Quality representative
• Ensure the execution, integration and coordination of CMC operational plan (timelines, resources, and deliverables) and monitor the operational progress through an operational meeting
• Analyze, monitor and report on CMC operational plan execution in alignment with CMC strategy, in particular define optimal plan for the critical path, to and ensure plan is on time, or propose contingency plan
• Contribute to project documents & governance meetings preparation (e.g. Technical Review meeting (in discussion with PL) CMC Board (draft the meeting minutes and ensure on time distribution), TARC, DWG and IDCC)
• Promote and ensure implementation of Good Project Management practices
• Support Business Development Licensing-in and
  -out projects. For inlicensing:
  As member of the CMC DD Team to prepare CMC project plan for potential licensing products and associated risk assessment and mitigations. Implementation of signed inlicensing deals. For out licensing:
  As member of the incoming CMC DD Team to prepare the Sanofi Due Diligence Virtual Data Room (VDR) of the out licensing project and once signed manage the transfer out to the licensor
• Support transversal initiatives contributing to simplification & harmonization and more generally the Project Excellence global team actions

• Bachelor's degree in sciences or engineering (Biotechnology, Chemistry, Gene Therapy, Microbiology etc.) with at least 7+ years of relevant experience in a pharmaceutical environment (industry or academia)
• PhD or MSc (Pharma
  
  D) preferred
• Past experience in project management
• Experience in managing international, multi disciplinary and/or multi-culture

• Excellent knowledge in CMC development, R&D and Industrial interfaces
• Excellent skills in Project Management
• Excellent English oral and written communication skills
• Able to lead transversely a…