POSITION OVERVIEW / DEPARTMENT DESCRIPTION:
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 Cell Therapy Compliance Specialist. 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.
This role is to support clinical manufacturing, as a cell therapy manufacturing specialist in Framingham, MA.
Enable the manufacturing of cell therapy products for clinical supply
Own, manage and execute Change Controls, LIRs, OTN and site deviations.
Work cross-functionally and in collaboration with internal support departments and manufacturing suite to develop or update internal policies, procedures or steps, communicates changes and plan for execution.
Own, manage, and monitor functional area project and tasks: Campaign support and readiness, MFG process specific change controls, Deviations, CAPA’s, Laboratory Investigation Reports (LIR) and Validation activities.
Identify, escalate and document events and variances that deviate from normal operation; participate as needed in investigations.
Liaison with Metrology department to ensure equipment is calibrated in a timely manner.
Assume a leadership role and participate in clinical manufacturing related activities that involve sterile/non-sterile conditions in a regulated cGMP environment
Bachelor's degree in sciences, engineering or equivalent discipline with 8-10 years of industry experience or a High school diploma/GED or Biotech Certification with a minimum of 11 years of industry experience
Experience leading a cross-functional team
Working knowledge and experience with Quality Systems including deviations and change controls
Excellent communication skills
Experience in cell therapy
Experience with GMP regulations
Experience in GMP documentation and compliance
Ability to operate and thrive in a fast-paced, high-growth environment
Track record in successfully demonstrating people management skills. including ability to develop self, build high performance teams, develop others and maintain accountability.
Master's degree with 2-5 years of industry experience
Knowledge of cell therapy manufacturing operations/ process
Experience in operational excellence tools such as Root Cause Analysis, Failure Modes and Effects Analysis, Value Stream Mapping, Kaizen, Statistical Process Control, SMED etc. preferred.
PMP, Lean Six Sigma Green certification
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
Strong skills in change management
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.
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.