CMC Project Manager

Job Title: CMC Project Manager

Location: 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.

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.

• 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

• 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 in licensing:
  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 in licensing 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, multidisciplinary and/or multicultural teams

• 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 multidisciplinary & multicultural team
• Excellent negotiation skills
• Experience with MS Office Suite (Excel, Word, PowerPoint), MS365 environment, flow diagramming and MS Project required and Thinkcell

• Put the interest of the organization ahead of own of those of his/her team
• Act in the interest of our patients and customers
• Take action and don’t wait to be told what to do
• Viewed as a leader by team member to drive the plan execution
• Lead by influence
• Ability to challenge the status quo

• Country Head of Project…