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Scientist Bioanalytics Cellular Therapies

Company: Sanofi
Location: Framingham
Posted on: June 25, 2022

Job Description:

This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi's CMC Development organization. The GMU Cell Therapy Analytical Development and Quality Control (CT AD/QC) 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 cellular 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 molecular biology and cell-based assay development to join the GMU CT AD/QC group in Framingham MA (this role will be moving to Waltham in Q3 2022).Overview of role:The primary accountability is to develop immunological, cell-based, and analytical methods, cGMP testing, and validation activities. In addition, the GMU CT 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.Key ResponsibilitiesDevelop, qualify, and transfer analytical methods to support drug substance and drug product release and stability testingEvaluate and implement new technologies within the CT AD/QC department, with an emphasis on state-of-the-art immunology, cell-based, and analytical assaysPlan, prioritize, and execute simple and complex experiments with the relevant controls, independentlyTroubleshoot existing protocols to increase method performance, throughput, and ergonomic controlWrite analytical sections of IND/IMPD filingsMay represents analytical development in cross functional meetings for projects and analytical initiativesWork in a cGMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followedLeads internal and external assay transfers consistent with established Sanofi proceduresMay provide technical oversight and manage the workload for a few junior analystsBasic QualificationsPh.D. in Molecular Biology/Biochemistry/Biology or related discipline or Master's degree with a minimum of four years of relevant industry experience, or a Bachelor's Degree with a minimum of six years of relevant industry experienceExcellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approachesSelf-motivated with excellent organization, time-management, and communication skillsInnovative, critical, and creative thinker; not afraid to propose disruptive solutionsPreferred QualificationsStrong background in immunology, cell-based, and/or analytical assays (including familiarity with equipment from different vendors), Experience in a cGMP environment and ability to adhere to all appropriate cGMP standards (e.g. invalid result investigations, deviations, and CAPAs)Experience with transferring methods between groups, preferably in a cGMP environmentExperience with validation and transfer analytical methodsExperience using Quality by Design (QbD) principles and have used Design of Experiment (DOE) approaches for method development/optimizationAt Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce - and workplace - which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.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.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. GD-SALI-SAPDNAt 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.PDN-95e861ab-2511-42c3-a72d-50e395a9fc79

Keywords: Sanofi, Framingham , Scientist Bioanalytics Cellular Therapies, Healthcare , Framingham, Massachusetts

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