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Sanofi Group Head of Cell Therapy Manufacturing Suite (CTMS) in Framingham, Massachusetts

Position Overview:

Sanofi’s Genomic Medicine Unit (GMU) CMC group is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors, and cell therapy products.

Sanofi is looking for a cell therapy leader with GMP manufacturing expertise to serve as Director of Cell Therapy Clinical Manufacturing. This is an exciting opportunity to join Sanofi’s GMU and be part of building the company’s cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions. Creativity, scientific thoroughness, entrepreneurial mindset, and ability to function in a complex environment are essential.

Key Responsibilities:

The primary accountability of this role is to enable the manufacturing of cell therapy products for clinical supply, oversee the implementation of clinical capable processes for manufacturing, and manage the startup of a cell therapy manufacturing suite in Framingham, MA. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.

Specifically:

  • Provide leadership to oversee the operation of a GMP cell therapy manufacturing suite.

  • Provide safe, effective and GMP compliant cell product for clinical studies according to project timelines and needs.

  • Ensure effective CAPEX, OPEX, and staff resource management.

  • Build an exceptional clinical manufacturing team to run the GMP operations.

  • Manage talent and people development within the organization.

  • Support the creation of high-quality CMC documentation for regulatory authorities and knowledge management.

  • Develop risk assessment and mitigation strategies to deliver manufacture cell therapy clinical product, including key uses of internal and external resources.

  • Report key milestones, bottlenecks, and accomplishments to ensure timely execution of goals.

  • Work with the Process and Product Development, Analytics and Quality organizations to ensure smooth transition from pre-clinical material generation to GMP production.

  • Work collaboratively with leaders throughout the global network to establish objectives, priorities, and directions, and represent the function in stakeholder meetings.

Basic Qualifications:

  • Master’s or Bachelor’s degree in relevant science or engineering discipline with a minimum of 14 years of experience in biotechnology or pharmaceutical industry.

  • Experience in managing a team (either within a line function or a cross-functional project team).

  • Experience in executing complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.

  • Experience with GMP regulations, a broad understanding of cell and gene therapy.

  • Extensive experience in compliance and GMP manufacturing with a proven track record in health authority quality audits.

  • Ability to operate and thrive in a fast-paced, high-growth environment.

  • Strong skills in change management.

  • Excellent communication skills.

Preferred Qualifications:

  • Advanced degree

  • Direct experience in building GMP manufacturing facilities to produce cell therapy, gene therapy, or biological drugs.

  • Expertise in CAR-T, NK cell therapy and demonstrated ability of taking a cell therapy-based product into clinical development.

  • Proven success and strong track record in building manufacturing organizations to deliver early phase clinical product.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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