Sanofi Group Scientist, Genomic Medicine Bioanalytics in Framingham, Massachusetts
This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Analytical Development group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different cell and gene therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.
We are looking for a skilled and highly motivated scientist with broad expertise in physicochemical method development to join the GMU Analytical Development and QC group in Framingham MA.
The primary accountability is to develop molecular and cell based methods, cGMP testing, and validation activities. In addition, the GMU AD QC team will be responsible for introducing new technologies and ways of working to enable rapid progression of various early stage cell and gene therapy candidates into the clinic.
Develop, qualify, and transfer analytical methods to support drug substance and drug product release and stability testing.
Evaluate and implement new technologies within the Analytical Development department, with an emphasis on state-of-the-art molecular and cell based and binding based assays.
Plan, prioritize and execute simple and complex experiments with the relevant controls independently.
Troubleshoot existing protocols to increase method performance, throughput and ergonomic control.
Write analytical sections of IND/IMPD filings.
May represents analytical development in cross functional meetings for projects and analytical initiatives.
Work in a cGMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed.
Leads internal and external assay transfers consistent with established Sanofi procedures.
May provide technical oversight and manage the workload for a few junior analysts.
Ph.D. in Biology/Biochemistry or related discipline or Master’s degree with a minimum of 4 years of relevant industry experience, or a Bachelor’s Degree with a minimum of 6 years of relevant industry experience.
Strong background in physicochemical methods (e.g. UPLC/HPLC, CE, cIEF including familiarity with equipment from different vendors), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches.
Experience with transferring methods between groups, preferably in a cGMP environment.
Self-motivated with excellent organization, time-management, and communication skills
Innovative, critical, and creative thinker, not afraid to propose disruptive solutions.
Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g. invalid result investigations, deviations, and CAPAs).
Experience with validation and transfer analytical methods.
Experience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimization.
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.