Sanofi Group Senior Research Associate, Clinical Biomarkers 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 and involves working on a team to execute specialized diagnostic bioanalysis to support late stage drug development and marketed products. This position will be working in a Good Clinical Laboratory Practice (GCLP) and Clinical Laboratory Improvement Act (CLIA)/State regulated environment. The position will focus on highly compliant, bioanalytical specialty testing. This will involve following procedures related to patient sample testing and various sample extraction techniques. This position also involves normalization of assays, instrument maintenance (Plate readers, plate washers, etc.), executing assays pertaining to development and validation of new methodologies and use of a validated LIMS system. This position will conduct reagent and instrument qualifications; provide training to junior staff and independently execute assays to stratify patients, and support of late stage drug development and commercial product launches. The candidate needs to be able to work independently and participating in team focused support to meet business needs. 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.
Bachelor's degree in life sciences from an accredited institution with 5+ years of experience or Master’s degree with 3+ years of experience in a regulated bioanalysis laboratory. Experience with ELISA, DNA/RNA extraction, PCR and basic sequence analysis required. Experience working in a compliant laboratory environment (GLP/GCLP) is required. Experience in handling and testing of patient samples and proficiency with Microsoft Office required.
Hands on experience with biomarker kit qualification and verification is preferred. 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.
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, Empowering Life