Scientist - Analytical Development GMU
Position Overview/Department Description
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.
- PhD in Biological Sciences (Cell Biology, Biochemistry, Immunology or related field) with a minimum of 0 - 2 years of relevant industry experience, 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.
- Understanding of MOA for protein, antibody and gene therapy-based therapeutics.
- Experience with flow cytometry, PCR, ELISA, western blotting, cell-based cytotoxicity/proliferation assays, and affinity/ligand platforms such as surface plasmon resonance.
- 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.
- Experience with validation and transfer 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.