Manufacturing Quality Assurance Specialist Cell Therapy

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 Cell Therapy Manufacturing 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. 

Key Responsibilities

• Support the manufacturing of cell therapy products for clinical supply.

• 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.

Basic Qualifications

• High school diploma/GED, Biotech Certification/Associate's degree with a minimum of 8 years of industry experience or a Bachelor’s degree in sciences, engineering or related discipline with a minimum of 5 years of industry experience or a Master’s degree with a minimum of 2 years of industry experience.

• Advanced technical knowledge of cell therapy manufacturing operations/ process.

• Working knowledge and experience with Quality Systems including deviations and change controls.

• Excellent communication skills.

• Experience with GMP regulations and cell therapy.

• Experience in GMP documentation and compliance.

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

Preferred Qualifications:

• 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.

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.