Sanofi Group Scientist, Gene Therapy Development - Cell Culture Development in Framingham, Massachusetts
Scientist, Gene Therapy Development - Cell Culture Development
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) 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.
Job Responsibilities/Department Description:
The Gene Therapy Development group is responsible for the development of production processes for early phase clinical programs . The upstream process development Scientist will be responsible for operations including mammalian cell line generation, upstream process development and material generation. The position will involve working with BSL-2 classified material using a broad array of cell culture platforms including shake flasks, spinners, cell factories, wave and stir tank bioreactors, in scales up to 250 liters. Additional responsibilities may include process transfer to internal and third party manufacturing sites.
Design and execute upstream process development activities for manufacture of gene therapy vectors. Manufacturing platforms may include stable mammalian packaging cell lines, Baculovirus production systems, or transient transfection.
Lead process scale-up and process definition activities, to include the execution of small-scale and at-scale bioreactor campaigns.
Participate in cell line generation, cell banking and stability assessment.
Evaluate emerging technologies for implementation into process development and vector manufacturing, e.g. high throughput systems bioreactor modeling, process analytical technology, etc.
Apply state of the art cell culture monitoring technologies; perform critical evaluation of cell culture performance data to identify trends and opportunities for improvement.
Document and communicate scientific data to line management and functional sub-teams through lab notebook entries, technical and monthly reports, and oral presentations.
Take ownership of and be accountable for development projects. Deliver on aggressive campaign schedules.
Adheres to and supports all safety programs by ensuring personnel safety training is completed and safety equipment is available.
Provide training and technical leadership to less experienced staff; incumbent may have managerial obligations for junior staff.
Ph.D. and 0-2 years of experience
Experience in cell culture technologies, including bioreactor systems.
Experience with cell banking technologies
Experience with aseptic cell culturing techniques in both flat stock adherent cultures (T-flasks/cell factories/roller bottles) and suspension systems (shake flasks, wave and stir tank bioreactors).
Experience with cell culture monitoring technologies including cell counting, metabolite and gas analysis and culture assessment.
Able to schedule multiple activities to maximize efficiency and productivity, including weekend schedules
Prior experience with cell culture process technology transfer to manufacturing setting is desirable, as is experience in a manufacturing setting with an understanding of current Good Manufacturing Practices (cGMP).
Experience with Baculovirus-based protein or virus production systems.
Experience with Quality by Design (QbD) and Design of Experiments (DOE) is a plus.
Familiarity with viral vector manufacturing systems and a BSL2 environment is a plus.
Must work effectively in a team. Must possess effective communication skills both written and oral. Will work to meet deadlines while adapting to changing priorities.
Job: Laboratory/Process/Device Development
Primary Location: United States-Massachusetts-Framingham
Job Posting: Oct 16, 2016, 10:03:24 AM
Job Type: Regular
Employee Status: Regular