Sanofi Group Sr Scientist in Framingham, Massachusetts
Job Responsibilities/Department description:
We are seeking a translational biomarker scientist to join our Biomarkers & Clinical Bioanalysis (BCB) global department within Translational Medicine unit of Sanofi. The position will be located in Framingham, MA (Boston area). Individual in this position should have experience in Biomarker strategy and in the development, validation, and implementation of assays to analyze biomarkers, pharmacokinetics, and immunogenicity. The candidate should have extensive hands on experience in developing assays to assess disease and treatment associated biomarkers with a focus on ligand-binding cell-based and enzymatic activity assays. immunophenotyping as well as experience in implementing biomarker strategies to support clinical development.
Responsibilities will include:
Work with global teams to develop and operationalize biomarker strategies to support new and ongoing clinical programs
Independently develop, validate and implement complex bioanalytical assays under the confines of challenging timelines
Serve as an operational lead for the department, ensuring compliance with internal practices and leading process improvement efforts
Serve as a lead in current best practices and regulatory guidances for biomarker analysis
Working closely with other team members as part of a coordinated effort to meet the business needs
Authoring SOPs, technical reports, abstracts, and publications and presenting scientific data to fellow colleagues
Work with outsourcing operational group and CROs to transfer and manage external testing efforts
Ph.D. degree in the field of biochemistry, immunology, biology, or other life-science field and 5 years of industry experience
A diverse skillset in bioanalytical assay development methodologies such as ligand binding (ELISA, MSD, etc.), immunophenotyping, cell-based neutralizing assays, multiplexed biomarker analysis, and enzymatic activity assays
Familiarity with basic statistical and data analysis software such as EXCEL, SoftMax Pro, JMP, GraphPad Prism, FlowJo, DIVA, etc
Familiar with regulatory expectations (FDA and EMA) and industry’s best practices in analytical assay development and validation of biomarker assays.
Outstanding written and oral communication skills along with ability to work collaboratively in a team setting
Experience working in a regulated environment in support of preclinical and clinical development projects, GLP, GCLP practices
Experience working with a laboratory information system to manage data and results
Experience supervising and directing the work of junior staff members in assay development efforts
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.