Principal Scientist

Principal Scientist – Waltham, MA Location: Waltham, MA About the Job: The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to establishing best‑in‑class manufacturing platforms to support development of advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors and cell therapy products. We are looking for an experienced cell culture development professional with expertise in cell therapy process development to join the Genomic Medicine Cell Therapy Process Development Group as a Senior Scientist. In this senior individual contributor role within the Upstream Scale‑Up Laboratory, you will be responsible for executing cell culture bioprocesses at pilot and manufacturing scales (200‑L to 2000‑L). You will serve as a technical cornerstone of the scale‑up team, providing process understanding, operational excellence, and cross‑functional alignment with downstream Scale‑Up Laboratory and manufacturing organizations. Responsibilities Lead scale‑up activities from bench scale to pilot scale (200‑L to 2000‑L), applying engineering principles (mixing, mass transfer, shear stress, dissolved oxygen control) to ensure process comparability at large scale. Collaborate with process development scientists to translate laboratory findings into scalable, robust manufacturing processes. Review and approve JSAs written by equipment owners and provide feedback. Train employees to adopt best practice for safety, efficiency and operational success. Build robust internal interfaces with the CMC community and promote the adoption of best practices. Demonstrate expertise in upstream process operations at all scales. Lead root cause analysis investigations for process deviations and equipment failures at pilot scale. Present findings and/or results to senior management, external stakeholders and industry leaders at national and international conferences. Qualifications Master’s degree in Chemical Engineering or a related discipline with a minimum of 6 years of relevant experience with large‑scale bioreactors, or a Ph.D. with a minimum of 4 years of industry experience related to large‑scale bioreactors. Strong background in cell culture bioreactor operations and scale‑up technologies. Experience in the biotech or pharmaceutical industry within a cell culture role and an excellent understanding of operational excellence. Experience with perfusion process operations at various scales. Understanding of engineering principles related to cell culture process. Ability to lead matrix teams for operations and laboratory management. Preferred Qualifications Experience managing cross‑functional teams and initiatives. Experience in cell culture process development for AAV manufacturing. Expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale‑up/down, and cell biology/physiology. Process automation experience. Benefits Competitive salary range: $122,250.00 – $176,583.33, commensurate with experience. Health and wellness benefits, including high‑quality health care, preventive and wellness programs. At least 14 weeks of gender‑neutral parental leave. Opportunities for career growth, including promotions and lateral moves, domestically and internationally. Sanofi Inc. and its U.S. affiliates are Equal Opportunity andAffirmativeAction 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, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including refusal to submit to genetic testing) or any other characteristic protected by law. #J-18808-Ljbffr