Sanofi Group Cell Culture Process Development Senior Scientist in Waltham, Massachusetts
The Genomic Medicine Unit (GMU) CMC group at Sanofi 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. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support.
The Genomic Medicine Cell Culture Process Development group is responsible for the development of AAV and Lentiviral vector production optimization and development of next generation production platforms to support high dose therapeutic products. The Scientist role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies in order to build robust and efficient production processes consistent with patient safety standards.
We are looking for a candidate with experience in AAV and/or LV cell culture development, high throughput screening models (e.g. Ambr 250), scale-up and manufacturing, and technology transfer.
Key Responsibilities :
Independently develop, design and conductviral vectorproductionexperiments and evaluate new technologies to increase product yield and process understandingusing design of experiment.
Develop, maintain and demonstrate advanced knowledge of principals and techniques incellculture, bioreactor operation,viral vectorproduction, process intensification andmedia development.
Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish findings as well asspeak both internally and externally as industry leaders.
Lead development of study design, optimization ofproductionprocess conditions, media screeningand perform troubleshooting experiments and communicate findings with appropriate working groups.
Perform data analyses,writeprotocols, author developmenttechnical reports, contribute to regulatory findingsandprovideinternaland external presentations.
Lead scale-up activities to implementa manufacturing process based on appliedcell cultureknowledge.
Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities.
Contribute to manuscript and patent writing for external publications and patent applications.
Assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.
Mentor and support junior staff and build a culture of support and collaboration.
Perform extended hours, weekend and holiday work to support ongoing lab activities.
PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or related discipline with a minimum of 4 years of relevant experience or a Master’s degree with a minimum of 8 years of experience or a Bachelor’s degree with a minimum of 10 years of experience.
Experience in executing projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
Experience with ambr250 process development.
Experience with large-scale cell culture operations.
Experience with process technology transfers and performing gap analyses and risk assessments.
Excellent communication skills.
Experience in the biotech/pharmaceutical industry within a cell culture role and an excellent understanding of the theory and practice of cell culture process development.
Strong understanding of the principles of Quality by Design and ability to apply DOE to upstream development.
Experience in the development of HeLa producer cell line production processes and/or HEK AAV transient transfection production.
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.