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CMC Project Manager

Sanofi
On-site
Cambridge, MA
Operations

Role Summary

The CMC Project Manager is a key contributor within the CMC Project Excellence department, delivering world-class CMC project management performance. The role enables efficient transversal collaboration inside and outside CMC, creating synergies across entities and ensuring projects deliver on time through strong project management practices.

Responsibilities

  • Translate CMC strategy into an operational plan and deliverables.
  • Operationalize the CMC strategy for a project into a CMC planning with an optimal critical path.
  • Develop CMC planning scenarios in collaboration with OPCM, the financial business partner Demand & Supply Leader, and other project SMEs.
  • Assess feasibility and optimize the CMC operational plan with Functions representatives and communicate to the CMC team.
  • Lead risk assessment and mitigation planning.
  • Integrate and deliver the supply plan as part of the CMC operational plan, ensuring alignment with overall project plans.
  • Coordinate DS and DP delivery and release on time for internal and external production, in coordination with Analytical and Quality representatives.
  • Oversee execution, integration, and coordination of the CMC operational plan, monitor progress via operational meetings.
  • Analyze and report on CMC plan execution, define optimal plans for the critical path, and propose contingency plans as needed.
  • Contribute to project documents and governance meetings (e.g., Technical Review, CMC Board, TARC, DWG, IDCC).
  • Promote and implement Good Project Management practices.
  • Support Business Development licensing-in and licensing-out projects, including due diligence and data room preparation and transfer.
  • Support transversal initiatives for simplification and harmonization within the Project Excellence/global team.

Qualifications

  • Required: Bachelor's degree in sciences or engineering (Biotechnology, Chemistry, Gene Therapy, Microbiology, etc.) with at least 7+ years of relevant pharmaceutical experience; past experience in project management.
  • Preferred: PhD or MSc (PharmaD).

Skills

  • Excellent knowledge of CMC development, R&D, and industrial interfaces.
  • Excellent project management skills.
  • Excellent English oral and written communication skills.
  • Ability to lead cross-functional, multidisciplinary, and multicultural teams.
  • Excellent negotiation skills.
  • Proficiency with MS Office Suite (Excel, Word, PowerPoint), MS365, flow diagramming, MS Project, and Thinkcell.

Education

  • Bachelor's degree in sciences or engineering (Biotechnology, Chemistry, Gene Therapy, Microbiology, etc.).
  • PhD or MSc (PharmaD) preferred.