CMC Project Manager

Job Title: CMC Project Manager

Location: Framingham, MA, Waltham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

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 are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• 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 outlicensing: As member of the incoming CMC DD Team to prepare the Sanofi Due Diligence Virtual Data Room (VDR) of the outlicensing 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.

Requirements

Education/Experience

• 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 Thinkscell

Technical skills & Competencies

• Excellent knowledge in CMC development, R&D and Industrial interfaces

• Excellent skills in Project Management

• Excellent English oral and written communicatio