Sanofi Group Senior Scientist, Genomic Medicine BioAnalytics in Framingham, Massachusetts
Position Overview/Department Description
This position resides within the newly established Genomic Medicine Unit (GMU) which is 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 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 group in Framingham MA.
Overview of role:
The primary responsibility of this role is to develop simple and complex physicochemical methods, oversee compendial verifications, and perform GMP testing and validation activities. In addition, this role is responsible for introducing new technologies and collaborating with the AD & QC team to develop new ways of working to enable rapid progression of various gene therapy candidates into the clinic.
Develop, qualify and transfer analytical methods to support drug substance and drug product GMP release and stability testing.
Evaluate and implement new technologies within the Analytical Development department, with an emphasis on state-of-the-art separation techniques (HPLC/UPLC and CE) and binding based assays.
Work in a GMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed.
Write/review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines.
Troubleshoot existing protocols to increase method performance, throughput and ergonomic control.
Write analytical sections of IND/IMPD filings.
Represent analytical development in cross functional meetings for projects and analytical initiatives.
Lead internal and external assay transfers consistent with established Sanofi procedures.
May provide technical oversight and manage the workload for a few junior analysts.
PhD in biological sciences with a minimum of 4 years of relevant industry experience or Masters degree with a minimum of 8 years or a Bachelors degree with a minimum of 10 years.
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 developing and implementing novel methods, preferably for gene and/or cell therapies, with proven troubleshooting skills.
Experience with transferring methods between groups, preferably in a GMP environment.
Proficiency with the use of chromatography data systems such as OpenLab, and/or Empower.
Innovative, critical and creative thinker, not afraid to propose disruptive solutions.
Excellent organizational and communication skills.
Experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs).
Experience in mentoring and managing direct reports
Knowledge of gene therapy regulatory guidance’s.
Experience as an analytical team leader, preferably for a gene or cell therapy project
Experience using QbD principles and tools e.g. DOE to develop analytical methods.
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.