Sanofi Group Senior Scientist, Bioassay and Molecular Analytical Development, GMU in Framingham, Massachusetts
We seek an innovative and dynamic Senior scientist to join the newly formed Bioassay and Molecular Analytical Development (BAM) group within the Genomic Medicine Unit (GMU)-Bioanalytics group in Framingham, MA. The candidate is expected to have a strong scientific background in cell-based assay and immunoassay development, as well as excellent oral and written communication skills. This successful candidate will play a key role in the design and development of cell-based potency assays as well as multicolor flow cytometry methods to support preclinical and clinical lot release and stability testing of cell and gene therapy products. Additionally, gene expression and infectivity titer assays may also be developed by the incumbent to support gene therapy potency assay development.
Lead and support method development and qualification of flow cytometry or cell-based assays and cell culture activities to support drug substance and drug product release and stability testing.
The incumbent will also be responsible for the development and implementation of binding assays such as cytokine & cellular protein ELISA as well as impurity assays such as detection of host cell proteins.
Independently, plan, prioritize and execute simple and complex experiments with the relevant controls with minimal guidance from their supervisor or subject matter experts.
Integrate, compile, analyze, and interpret data independently.
Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.).
May manage analysts involved in cGMP sample testing, following method protocols (SOPs) and generate data packets for results. Lead investigations into deviations and CAPA resolutions
Write technical reports & SOPs, including clear and concise technical data presentation and discussion. Present on technical aspects internally and externally.
Work within a broader cross functional team to support the development and implementation of new ways of working and methodologies.
PhD Degree in a relevant discipline and at least 4 years of relevant experience in Biology or associated disciplines, or Master’s Degree and at least 8 years of relevant experience or Bachelor’s Degree and at least 10 years of relevant experience.
Strong background in cell and molecular methods (e.g. Flow cytometry, ELISA, PCR or cell-based assays) and excellent method troubleshooting skills, as well as knowledge of various data analysis approaches.
Evaluate and implement new technologies within the Analytical Development department, with an emphasis on state-of-the-art molecular and cell based and binding based assays.
Ability to review, understand and implement methodologies described in scientific literature to relevant cell or gene therapy programs.
Must be organized and efficient and able to work according to timelines.
Excellent written and verbal communication skills.
Post-doctoral experience and strong publication record.
Understanding of MOA for cell and gene therapy-based therapeutics.
Experience in developing and analyzing immunoassays and/or quantitative cell-based and biochemical/immunological assays in the context of relative potency.
Familiarity with software packages to analyze dose-responses and statistical analysis (SoftMax, JMP, etc).
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.