Sanofi Group Senior Research Associate Mammalian Bioanalytics in Framingham, Massachusetts
Sanofi is seeking a highly motivated Senior Research Associate to join the Analytical Development team within Mammalian Bioanalytics, which develops, validates, and transfers analytical methods used for characterization and release of biologics. The successful candidate will participate in the development and validation of HPLC/UPLC, size exclusion chromatography (SEC), capillary electrophoresis (CE), ciEF and other physiochemical analytical methods. This individual will participate in testing of pre-clinical and clinical lot release and stability testing of biotherapeutics, including antibody, antibody-like, enzyme, and other therapeutics using these and other methods. Additionally, this job is within a cGMP setting requiring excellent verbal and written communication and involves collaboration with different departments.
Participate in the development, qualification, validation, and transfer of HPLC/UPLC, SEC, CE, ciEF and potentially other analytical methods in a regulated GMP environment.
Perform cGMP sample testing according to standard operating procedures (SOPs) and compile data packets.
Assist in the drafting of SOPs and technical reports and be able to effectively communicate progress and experimental results to supervisor and team members.
Ensure timely completion and delivery of all analytical results and documentation (technical reports, SOPs, ELN, LIMS, etc.) to support product development during clinical phases.
Bachelor's degree in analytical chemistry, biochemistry, or related discipline with a minimum of 2 years of relevant experience in the biotechnology/pharmaceutical industry or a Master's. degree in analytical chemistry, biochemistry, or related discipline.
Understanding of physicochemical methods e.g. SDS-PAGE, CE, HPLC, GC, CE, mass spectrometry.
Excellent organizational and time management skills
Ability to work collaboratively in a fast-paced, team-oriented environment
Must have permanent US work authorization.
Hands-on experience with UPLC/HPLC, SEC, cIEF or other protein separation techniques in a pharmaceutical or biotechnology setting.
Experience with chromatographic software applications such as Empower or OpenLab.
Experience with method development and/or validation in a GLP/GxP environment.
Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs).
Proficient in Microsoft Word, Excel, PowerPoint, and ELN.
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.