Sanofi is seeking a highly motivated Senior Research Associate to join the Analytical Development and QC group within Mammalian Bioanalytics, located in Framingham, MA. The Analytical Development group has the overall responsibility to establish phase-appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different antibody and protein therapeutics candidates. In addition, the AD group is responsible for cGMP-compliant release and stability testing of clinical supplies and performs both compendial as well as product-specific methods. The goal of all these activities is to enable rapid progression of multiple therapeutic candidates into the clinic. Main Responsibilities include contributing to the development, qualification, and transfer of analytical methods in support of drug substance and drug product release and stability testing; planning and performing experimental procedures across multiple development projects simultaneously and documenting the work in an electronic lab notebook; integrating, compiling, analyzing, and interpreting data with some supervision; performing cGMP sample testing, following method protocols (SOPs), and compiling and reviewing data packets; assisting in the drafting of SOPs and technical reports and effectively communicating progress and experimental results to supervisor and team members; ensuring timely completion and delivery of all analytical results and documentation to support product development during clinical phases. Basic Qualifications include a B.S. degree in Analytical Chemistry, Biochemistry, or related discipline with a minimum of 2 years of relevant experience in the biotechnology/pharmaceutical industry or M.S. degree with 0-2 years of relevant experience; basic understanding of physicochemical methods such as Capillary Electrophoresis, cIEF, and HPLC and exposure to chromatographic software applications; excellent written and verbal communication skills; ability to work collaboratively in a fast-paced, team-oriented environment. Preferred Qualifications include hands-on experience with CE-SDS, cIEF, or other protein separation techniques in a pharmaceutical or biotechnology setting; a minimum of 1 year experience in a GMP laboratory; experience with chromatographic software applications such as 32Karat and Empower; must be organized, efficient, and able to work according to timelines.
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