Sanofi Group Associate Director GMU CMC Cell Culture Process Development in Waltham, Massachusetts
Position Overview/Department Description
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 professionalwith experience in viral vector productionto join theGenomic MedicineCell CultureProcessDevelopment Group located inWaltham, MA inthe role ofAssociate Director. TheGenomic MedicineCell Culture Development group within Sanofi operates with the mission to develop robust, scalable and innovativeviral vectorcell culture processes for Sanofi’sgenomic medicinepipeline. 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, andproject management skills.
Job Duties and Responsibilities
Lead a group of scientists and engineers responsible for the development of viral vector cell culture processes,andtechnology transfer to manufacturing sites,
Makes strongtechnical,strategic contributions to cross functional development project teams
Oversee the processdevelopment andscale-up operations, defining scale down models and authoringassociated regulatory filing activities
Responsible for successful viral vector process development, process characterization and execution of upstream manufacturing processesManagesa multi project development portfolio
Establishand linkviral vectorbiology/molecular understanding with viral vectorprocess development understanding
Lead projects to develop and implement industry leading viral vector cell culture production technologies
Drive innovationto enhance viral vector productivityand quality.
Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.
Authormanuscripts and patent applications.
Build stronginterfaces withGMU CMCcommunity and help drive adoption of best practices
PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or relateddisciplinewitha minimum of8years of relevant experience oraMaster’sdegreewitha minimum of12years 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-AssociatedVirus biology, is highly desired
Strong cell culture expertiseandknowledge pertaining to AAV and/or LVproduction
Abilityto manage multiple projects in parallel, including key participation in cross functional project and innovation teams
Minimum of5years ofexperiencemanaging direct reports or project teams
Excellent communication skills
Experiencemanaging 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.