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Sanofi Group Scientist - Analytical Development GMU in Waltham, Massachusetts

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 and molecular assays to support product characterization studies, process development, and preclinical and clinical lot release and stability testing of viral (AAV) and non-viral gene therapeutics, including LNP/mRNA/DNA modalities. A successful candidate will have a strong scientific background in developing analytical methods, 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, immunoassays, and molecular assays including qPCR and digital PCR

  • Evaluate and implement new technologies within the GMU Analytical Development Team, with an emphasis on state-of-the-art analytical assays for gene therapy products

  • Participate in the development, qualification, and validation of analytical methods

  • Ensure timely completion and delivery of analytical results with GMP 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 regulatory requirements

Basic Qualifications

  • PhD in Biological Sciences (Cell Biology, Biochemistry, Molecular Biology or related field) or 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 analytical methods

Preferred Qualifications

  • Understanding of MOA for gene therapy-based therapeutics

  • Experience with quantitative PCR including primer design, digital PCR, ELISA, cell-based relative potency assays

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

  • Familiarity 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 of analytical methods according to ICH guidelines

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.

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.