Job Description:
About the Job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Sanofi is seeking a highly motivated Scientist to join the Analytical Development team in our growing Genomic Medicines Unit (GMU) in Waltham, MA. The candidate will play a critical role in the design and development of cell-based potency and immunological assays to support product characterization studies, process development, and preclinical and clinical lot release and stability testing of viral and non-viral gene therapeutics, including LNP/mRNA/DNA modalities. A successful candidate will 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.
- Define scientific approaches and analysis methods for quantitative bioassays, immunoassays, and molecular assays
- Evaluate and implement new technologies within the GMU Analytical Development Team, with an emphasis on state-of-the-art immunology, cell-based, and analytical assays
- 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 analytical sections of IND/IMPD filings
- Write and review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines.
About You
- Earned PhD in Biological Sciences (Cell Biology, Biochemistry, Immunology or related field) with up to 2 years of relevant industry experience (preferred), OR Master's degree in a relevant discipline and at least 4 years of relevant experience, OR Bachelor's degree in relevant discipline and at least 6 years of relevant experience.
- Experience in developing and analyzing quantitative cell-based and biochemical/immunological assays in the context of relative potency is ideal.
- Working experience in GMP environment will be considered an advantage.
- Understanding of MOA for protein, antibody and gene therapy-based therapeutics is preferred.
- Experience with flow cytometry, PCR, ELISA, western blotting, cell-based cytotoxicity/proliferation assays, and affinity/ligand platforms such as surface plasmon resonance is greatly preferred.
- Familiarity with software packages to analyze dose-responses and statistical analysis (SoftMax, JMP, etc) is helpful.
- Familiar with QbD principles and DOE approaches for method development and optimization.
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Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
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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