Sanofi Group Manager Lab in Framingham, Massachusetts

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 lead a group of 2-3 scientific associates to execute high complexity analytical assays to meet regulatory submission and business needs. 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 managing clinical assay development and validation as well as strategizing procedures for longitudinal testing. Candidate will manage laboratory quality activities and work closely with quality system. The position will author assay development and validation plan/reports. This position requires strict attention to details and compliant laboratory activities.

The candidate will work closely with clinical trial/study managers and serves as a BCB project lead for multiple programs. The candidate will attend clinical trial team and global business meetings as needed.

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 application of ABI 3730, Luminex (xTag technolog), Nanostring MiSeq (NGS), QIAxcel capillary electrophoresis instrument, and Nanodrop required. Knowledge of GLP/GCLP/CLIA is required.

  • Proficiency with Microsoft Office required. Previous experience in Human Genetics is required.

Preferred Qualifications:

  • Hands on experience with Immunocellular assays as well as immunohistochemistry staining are highly desirable. Knowledge of companion diagnostics and IVD is 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