CMC Project Manager jobs in United States
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Sanofi · 1 day ago

CMC Project Manager

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The CMC Project Manager will be responsible for translating CMC strategy into operational plans, ensuring project deliverables are met on time, and fostering collaboration across CMC entities.

Health CareLife SciencePharmaceuticalTherapeutics
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H1B Sponsor Likelynote

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

Qualification

CMC developmentPharmaceutical experienceProject ManagementMS Office SuiteNegotiation skillsMulticultural team leadershipRisk assessmentLeanAgile toolsCommunication

Required

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)
Past experience in project management
Experience in managing international, multi disciplinary and/or multi-cultural 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

Preferred

PhD or MSc (PharmaD)

Benefits

High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave

Company

Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.

H1B Sponsorship

Sanofi has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)

Funding

Current Stage
Public Company
Total Funding
$6.97B
Key Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B

Leadership Team

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Paul Hudson
Chief Executive Officer
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Francois-Xavier Roger
Chief Financial Officer
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Company data provided by crunchbase