Sanofi Group Genomic Medicine Bioanalytics – Flow Cytometry, Principal Research Associate 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. The group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.
The focus of this role is to develop simple and complex physicochemical methods, as well as to perform compendial verifications, cGMP testing and validation activities. In addition, contribute to a team responsible for introducing new technologies and ways of working to enable rapid progression of various early stage gene therapy candidates into the clinic. The candidate will work with the team to facilitate these goals. This group will be moving to Waltham, MA June 2022.
Develop, qualify, and transfer analytical methods to support drug substance and drug product release and stability testing.
Plan, prioritize and execute simple and complex experiments with the relevant controls with little guidance from their supervisor.
Integrate, compile, analyze, and interpret data with minimal supervision.
Write simple technical reports & SOPs, including clear and concise technical data presentation and discussion.
Perform cGMP sample testing, following method protocols (SOPs), and generate data packets for results.
Work within a broader team to support the development and implementation of new ways of working and methodologies.
Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.).
Master’s Degree in Biology/Biochemistry or similar discipline and at least 2 years of relevant industry experience, or a Bachelor’s Degree in Biology/Biochemistry or similar discipline and at least 4 years of relevant industry experience.
Experience using and developing molecular techniques such as physicochemical methods (e.g. UPLC/HPLC, CE, cIEF including familiarity with equipment from different vendors).
Basic understanding molecular procedures and technologies with proven ability to interpret and present data.
A minimum of 1 year experience in a cGMP environment.
Experience 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.