Senior Scientist Bioassay Development and Quality Control

Job Title: Senior Scientist Bioassay Development and Quality ControlLocation: Waltham, MAAbout the Job:Opportunity to join a fast-paced Gene Therapy bioanalytical team focusing on potency method development, qualification, QC testing and CRO transfer in a compliant GMP environment. This position will improve analytical capacity for the potency team, allowing more programs to progress efficiently through early phase development. The successful candidate will be responsible for method development for multiple viral and non-viral gene therapies through hands-on work including method development and optimization, SOP and report writing and providing group presentations. This is a great opportunity for an energetic and dedicated team player willing to do what it takes to support our goal of releasing critical medicines to patients. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.About Sanofi:We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.Main Responsibilities:Responsible for early-stage GMP release testing and maintaining a GMP compliant environment.Serve as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassaysDevelopment, qualification and validation and transfer of analytical methodsMaster Sanofi quality systems providing expertise and coaching to team membersPerform analytical support testing, ensuring timely completion and delivery of analytical results with appropriate documentation to support product development during clinical phasesParticipate in analytical leadership teams for viral and non-viral programsTake an active role in Lab maintenance, organization, GMP and safety complianceEnsure compliant use of electronic notebooksWork in a matrixed environment and interact productively with associates, scientists and management at various levels, both locally and internationallyAbout You:Education:PhD in Biological Sciences or related fields, Master's Degree (MS) will be considered.2+ years of experience in a GMP environment (required)4+ years of relevant industry experience, including gene therapy (preferred)Experience & Technical Skills:Bioassay development experienceExperience in performing QC release and stability assaysAptitude to manage multiple types of quality events including deviations, change controls, lab investigationsPreferred Qualifications:Experience with flow cytometry, FRET-assays, effector function assays, reporter cell lines, PCR analysis and/or ELISA endpoints, DOE approaches where appropriateExperience automating cell-based assaysComprehensive knowledge of gene therapy analytics including potency and impurity paradigms, knowledge of gene therapy regulatory guidanceExperience performing analytical support for structure/function and in-process studiesKnowledge of various approaches to data analysis, strong understanding of relative potency assay analysis including software and regulatory expectationsExperience in technology transfer to other sites Experience with BioVia productsWhy choose us?Bring the miracles of science to life alongside a supportive, future-focused team.​​Discover endless opportunities through working with a talented and dedicated team in an integrated environment. Grow your talent and drive your career in gene therapy. 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.​Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.Help improve the lives of millions of people globally by making drug development quicker and more effective.Sanofi US Services and its U.S. affiliates are