Sanofi Group Principal Research Associate, Clinical Biomarkers in Framingham, Massachusetts

Job Responsibilities/Department Description:

Clinical Diagnostics is a CLIA accredited high-complexity laboratory within Sanofi R&D to support late stage clinical development and marketed drugs.

The position is located in the TMED/BCB-Clinical Diagnostics group to provide specialized diagnostics bioanalysis and scientific expertise to support late stage drug development and marketed products. This position is working in Good Clinical Laboratory Practice (GCLP) and Clinical Laboratory Improvement Act (CLIA)/State regulated environment. This position will design, interpret, execute high complexity analytical assays and evaluate/define technology platform to meet regulatory submission. The position works closely with senior managers for regulatory/companion diagnostics filing. The position will focus on implementation of new methodology in support of late stage drug development and commercial product launches. Activities would include clinical assay design, validation as well as strategizing procedures for long-term assay support and patient sample testing. Responsible for maintenance and troubleshooting of the high complexity instruments (e.g., Immunochemistry Analyzer, Quant studio 12K flex, ABI 3730). The candidate works independently with little to no supervision. Defines and implements a series of experiments to solve a problem and serve as a technology lead to oversee and train junior researcher, while participating in team focused support to meet business need. Designs and maintains critical reagents including molecular biology reagents (e.g. PCR primers) as necessary. Evaluates reagent for clinical assay use, and prepares final documentation such as certificate of analysis. Candidate will be involved in tracking quality control trending for early identification of assay issues. The position will author assay Validation Plan/Reports and new standard operating procedures and initiate revisions on current procedures as applicable. This position requires strict attention to details and compliant laboratory activities. Being able to follow standard operating procedures, laboratory quality assurance documentation, and handling of patient test data is absolutely critical to succeed with this position.

Qualifications

Basic Qualifications:

  • Bachelor's degree in life sciences with 8+ years of experience or Master’s degree with 5+ years of experience in a regulated bioanalysis laboratory required.

  • Experience with assay development and validation, biomarker kit qualification required.

  • Hands on experience with molecular biology methods, including DNA/RNA extractions, gel electrophoresis, capillary electrophoresis, primer design, PCR, quantitative PCR and DNA sequence analysis required.

  • Knowledge of operation and maintenance of Quant studio 12K flex, ABI 3730, QIAxcel capillary electrophoresis instrument, and Nanodrop required.

  • Experience working in a compliant laboratory environment (GLP/GCLP/CLIA) is required.

  • Familiarity with Nanostring and Luminex platforms and xTag technology is highly desirable.

  • Experience in handling and testing of patient samples is required. Proficiency with Microsoft Office required. Experience with Filemaker Pro is a plus.

  • Knowledge of companion diagnostics and IVD is highly desirable. Familiarity with NGS and/or IHC technology platforms is desirable. Knowledge of state/CLIA regulatory practices would be a plus.

Preferred Qualifications:

  • Previous experience in human Genotyping in rare disease area is preferred. Hands on experience with Immunocellular assays as well as immunohistochemistry staining are highly desirable.

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life