Sanofi Group Process Engineer, Manager, Gene Therapy Upstream in Framingham, Massachusetts
Process Engineer, Manager, Gene Therapy Upstream
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 lead the upstream process development team responsible for the design of robust and scalable gene therapy manufacturing processes. Additional responsibilities may include leadership roles on CMC development teams and technology transfer teams.
Manage the Gene Therapy upstream process development staff by providing technical leadership and identification of training opportunities for direct reports.
Lead the design and execution of 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.
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. Incumbent may contribute to regulatory filings.
Take ownership of and be accountable for development projects. Deliver on aggressive campaign schedules.
Ph.D. and 0-2 years or Masters and 8 years or Bachelor’s and 10 years of experience.
Minimum 3 years of relevant experience in cell culture technologies, including bioreactor systems.
Experience with cell banking technologies
Proficient 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.
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.
Ability to schedule multiple activities to maximize efficiency and productivity, including weekend schedules.
Job: Engineering & Maintenance
Primary Location: United States-Massachusetts-Framingham
Job Posting: Sep 19, 2016, 11:50:00 PM
Job Type: Regular
Employee Status: Regular