Job Title: Senior Associate Scientist Location: Framingham, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Bioanalytics Analytical development 2 team as Senior Associate Scientist and you’ll play an integral role in delivering quality products to patients. The Impurities and potency assay development group in Bioanalytics develops plate based assays to support monoclonal antibody and enzyme replacement therapy products in Sanofi. The team uses a number of technologies to evaluate these critical quality attributes for our products. We are seeking a motivated full-time employee to work as a member of the Bioanalytics team supporting development, transfer and testing of binding and impurity assays for programs within Sanofi. The successful candidate will work under supervision to support development, qualification and validation of analytical methods as needed. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Perform method development for binding assay methodologies including ELISA, and ELISA based methods for example, MesoScale Discovery (MSD) for binding and impurity assays. Manage work assignments, analyze and interpret test results, and conduct necessary troubleshooting under the supervision of the manager. Author SOP’s, method development and qualification reports, and present work at relevant internal meetings as needed. Interact with external laboratories to transfer methods, review feasibility data, give input on method validation, and troubleshoot experiments as needed. Ability to travel to external sites to aid method transfer may be needed on a case by case basis. Interact with Sanofi colleagues across the global Bioanalytics organization to participate in discussions on method harmonization. Flexibility to learn new or additional techniques and methodologies to support other groups within the greater BioA organization to meet CMC project deliverables. Successfully train and support sample testing (GMP and non-GMP) for Sanofi programs. Document the data per department policies in the relevant data packets or Electronic lab notebooks, in a timely manner. Ensure and Drive GMP compliance by supporting equipment and lab maintenance on a routine basis. Experience working in a QC laboratory a plus. The associate is expected to support the training of additional operators and the establishment of new methods and processes as needed. Must be able to work collaboratively in a fast paced, team-oriented environment. About You Experience: Experience with development and sample testing using Host cell protein/impurity-based ELISA assays. Technical expertise in development, testing of potency assays (binding ELISA based or cell-based assays). Understands concepts of method qualification, validation and transfer in a regulated environment. Experience working in a QC laboratory or GMP environment. Proficient in Microsoft Word, Excel, PowerPoint, has utilized plate based software such as SoftMax Pro. Must be a team player, organized and efficient and able to work according to timelines. Soft and technical skills: Excellent communication skills, proactive communication regarding project progress to team members and manager, good technical writing skills. Being a team player by supporting the team by training and supporting multiple assays as needed. Education: BS degree in Biology with a minimum of 2 years of experience in development of ELISA based methods or Master’s degree in Biology or related sciences with similar ELISA experience. Languages: English Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 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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