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 cell-based, binding, and molecular 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 and requires excellent verbal and written communication across several departments.
Participate in the development, qualification and validation of cell-based bioassays, molecular assays (e.g. qPCR), and potentially other analytical methods in a regulated GMP environment.
Participate in the execution of lot release and stability tests (e.g. cell-based assays, qPCR, etc.) for drug substance and drug product, and documentation of data packages under GMP.
Draft technical reports and effectively communicate results in project team meetings when needed.
Ensure timely completion and delivery of all analytical results and documentation (technical reports, SOPs, ELN, LIMS, etc.) to support product development during clinical phases.
B.S. degree in Biochemistry, Biology, or related discipline with a minimum of 2 years of relevant industry experience in the biotechnology/pharmaceutical industry or M.S. degree in Biochemistry, Biology, or related discipline.
Must be organized, efficient, and able to work according to timelines.
Must be able to work collaboratively in a fast-paced, team-oriented environment.
Must have permanent US work authorization
Experience with cell-based and PCR assays in a pharmaceutical or biotechnology setting.
Experience with aseptic technique and tissue culture.
Experience with method development and/or validation.
Experience with additional analytical techniques (e.g. SDS-PAGE, CE-SDS, HPLC, etc.) is a plus.
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 JMP.
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.