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A Range of Possibilities

Manufacturing Manager Clinical Cell Therapy

date posted 09/23/2022
contract type Full time
job id R2648666
location 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 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.

Key Responsibilities:

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.

Specifically:

  • 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.

Basic Qualifications:

  • 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.

Preferred Qualifications:

  • 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. 

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.  

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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.

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