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 Manager of Clinical Cell Therapy 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.
The primary accountability of this role is to enable the manufacturing of cell therapy products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing suite in Framingham, MA. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.
Provide leadership to oversee the operation of a GMP cell therapy manufacturing operations team.
Manage operational staff, including developing staff capabilities through initial and ongoing training and maintaining team compliance.
Provide management oversight of tech transfer activities.
Provide management oversight of drug products production.
Manage the production schedule and the daily tasks of the Manufacturing Operators.
Provide oversight and guidance related to training materials, SOPs, batch records, reports, risk assessments, materials management, etc.
Work cross-functionally with process development, quality, and other counterparts for the development of next-generation cGMP cell therapy manufacturing processes.
Works closely with senior management to initiate new projects and assist in developing processes/techniques to meet business objectives.
Bachelor’s degree in sciences, engineering or related discipline with a minimum of 8 years of industry experience or a Master’s degree with a minimum of 6 years of industry experience.
A minimum of 2 years managing direct reports or project teams.
Experience in GMP documentation and compliance.
Ability to operate and thrive in a fast-paced, high-growth environment.
Strong skills in change management.
Excellent communication skills.
Cell Therapy experience
PhD in a sciences or engineering discipline.
Direct experience in cell GMP manufacturing facilities with expertise in CAR-T, NK cell therapy.
Involvement in delivering a cell therapy-based product into clinical development.
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.