CMC Project Manager

CMC Project Manager

Requirements

• BS in Sciences or Engineer degree (Biology, Biotechnology, Chemistry, etc.) with at least 7-10 years’ experience in CMC Development. PhD or MS in Sciences or Engineering degree with 5+ years of experience.
• Past experience in project management.
• Experience in managing international, multi-disciplinary and/or multi-cultural teams
• Experience in viral, and/or non-viral therapy a plus
• MsSC (PharmaD) preferred
• 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

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.

Preferred Qualifications

• Experience in viral, and/or non-viral therapy a plus
• MsSC (PharmaD) preferred