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Sanofi Group Scientist Bioassays in Framingham, Massachusetts

Position Overview:

Sanofi is seeking a highly motivated Scientist to join the Analytical Development team in Bioanalytics, Framingham, MA. The candidate will play a key role in the design and development of cell-based potency assays to support preclinical and clinical lot release and stability testing of biotherapeutics, including enzymes, antibodies and other therapeutic platforms. As such, a successful candidate would have a strong scientific background in cell-based assay and immunoassay development, excellent oral and written communication skills, and a team player approach to problem-solving.

Job Responsibilities:

  • Define scientific approaches and analysis methods for quantitative bioassays.

  • Participate in the development, qualification and validation of bioassays and immunoassays.

  • Ensure timely completion and delivery of analytical results and documentation to support product development during clinical phases.

  • Write and review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines.

Basic Qualifications:

  • PhD in Biological Sciences (Cell Biology, Biochemistry, Immunology or related field) or Master’s Degree with a minimum of 4 years of relevant industry experience, or Bachelor’s Degree and a minimum of 6 years of relevant industry experience.

  • Experience in developing and analyzing quantitative cell-based and biochemical/immunological assays in the context of relative potency.

Preferred Qualifications:

  • Understanding of MOA for protein, antibody and gene therapy-based therapeutics.

  • Experience with flow cytometry, ELISA, western blotting, cell-based cytotoxicity/proliferation assays and effector function assays (ADCC, CDC, FcyR binding, C1q binding) to characterize antibody therapeutics.

  • Familiarity with software packages to analyze dose-responses and statistical analysis (SoftMax, JMP, etc).

  • Familiar with QbD principles and DOE approaches for method development and optimization.

  • Working experience in GMP environment will be considered an advantage.

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.

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