CMC Project Manager

Role Summary

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 role 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 to ensure projects deliverables are met on time.

Responsibilities

• Responsible for translating CMC strategy into an operational plan and 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 and mitigation plan.
• 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 the 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, define optimal plan for the critical path, and propose contingency plans as needed.
• Contribute to project documents and governance meetings preparation (e.g., Technical Review meetings, CMC Board, TARC, DWG and IDCC).
• Promote and ensure implementation of Good Project Management practices.
• Support Business Development Licensing-in and -out projects, including risk assessment and mitigations for in-licensing and due diligence data room transfer for out-licensing.
• Support transversal initiatives contributing to simplification and harmonization and broader Project Excellence actions.

Qualifications

• 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 (PharmaD) preferred.
• Past experience in project management.
• Experience in managing international, multidisciplinary and/or multicultural teams.

Skills

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

Education

• Bachelor's degree in sciences or engineering required; advanced degree preferred.