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. Sanofi is looking for an experienced cell culture development professional with experience in viral vector production to join the Genomic Medicine Cell Culture Process Development Group located in Waltham, MA in the role of Associate Director. The Genomic Medicine Cell Culture Development group within Sanofi operates with the mission to develop robust, scalable and innovative viral vector cell culture processes for Sanofi's genomic medicine pipeline. The successful applicant will lead a group of scientists and engineers responsible for the development of viral vector cell culture processes, technology transfer to manufacturing sites, overseeing process scale up operations, defining scale down models, and authoring of associated regulatory filing activities. We are looking for a candidate with excellent scientific, communication, and project management skills.Key Responsibilities:
- Lead a group of scientists and engineers responsible for the development of viral vector cell culture processes, and technology transfer to manufacturing sites.
- Makes strong technical, strategic contributions to cross functional development project teams.
- Oversee the process development and scale-up operations, defining scale down models and authoring associated regulatory filing activities.
- Responsible for successful viral vector process development, process characterization and execution of upstream manufacturing processes Manages a multi project development portfolio.
- Establish and link viral vector biology/molecular understanding with viral vector process development understanding.
- Lead projects to develop and implement industry leading viral vector cell culture production technologies.
- Drive innovation to enhance viral vector productivity and quality.
- Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.
- Author manuscripts and patent applications.
- Build strong interfaces with GMU CMC community and help drive adoption of best practices.
- PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or related discipline with a minimum of 8 years of relevant experience or a Master's degree with a minimum of 12 years of experience.
- Experience in executing projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
- 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 is required.
- Molecular understanding of viral vector productions, in particular Adeno-Associated Virus biology, is highly desired.
- Strong cell culture expertise and knowledge pertaining to AAV and/or LV production.
- Ability to manage multiple projects in parallel, including key participation in cross functional project and innovation teams.
- Minimum of 5 years of experience managing direct reports or project teams.
- Excellent communication skills.
- Experience managing cross functional team and initiatives.
- Experience in media development.
- Understanding of cell metabolism, metabolic flux, PAT or omics technologies would be particularly desirable along with knowledge and experience in using system biology approach to gain deep biology understanding.
- Experience in the development of HeLa producer cell line production processes and/or HEK AAV transient transfection production.
- Experience in scale up and scale down of bioreactor processes.
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.