Scientist, Downstream Process Scale-Up

Job Title: Scientist Location: Waltham, MA About the Job: The Genomic Medicine Unit (GMU) Chemistry, Manufacturing and Control (CMC) group at Sanofi is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors and non-viral vectors. This organization encompasses vector and cell line engineering, upstream and downstream process development, analytics, and clinical manufacturing support. The GMU purification process development group is responsible for the development of AAV viral vector processes and for supporting viral vector purification for next-generation production platforms to enable high-dose gene therapy programs. The Scientist role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of novel technologies in order to build robust and efficient purification processes consistent with patient safety standards. We are looking for a candidate with hands-on experience executing downstream purification at pilot and large scale, with a strong background in scale-up and some exposure to technology transfer. Experience across biologics modalities is valued, and experience with AAV or other viral vectors is a plus. 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: Lead the execution and scale-up of downstream purification manufacturing, from 50-L pilot through 2000-L scale, partnering with CMC project teams on logistical planning for pre-clinical manufacturing campaigns Lead the authoring, review, and revision of SOPs, batch records, and batch reports for pilot and large-scale downstream operations Perform data analyses supporting pilot and large-scale DSP manufacturing, and contribute to technical reports and internal/external presentations Lead troubleshooting of manufacturing issues and communicate findings to appropriate working groups Maintain critical process equipment and consumables to minimize downtime, and lead or support evaluation of new process technologies to improve yield, cost, and cycle times Support digital transformation and continuous improvement initiatives within GMU CMC (e.g., electronic batch records, process data capture, workflow enhancements) Develop and maintain advanced knowledge of column chromatography, filtration, and related purification technologies; mentor junior staff and foster a collaborative team culture About You: Education: Master’s degree in chemical or biochemical engineering or related disciplines with a minimum of 2 years of relevant experience or a bachelor’s degree with a minimum of 4 years of relevant experience Experience & Technical Skills: Significant experience of working with pilot- and large-scale DSP manufacturing unit operations Significant experience, knowledge, and understanding of purification technologies and operations. Required: Hands-on experience with Chromatography and Tangential Flow Filtration (TFF) Preferred: Experience with Depth Filtration and/or Viral Filtration/Inactivation. Experience with process technology transfers and performing gap analyses and risk assessments Expertise in drafting batch records and SOPs (required); experience authoring technical reports (preferred). Preferred Qualifications: Experience in AAV purification development Experience in CMC and drug development Experience with digital solutions to enable efficient manufacturing operations (e.g. electronic batch records, electronic notebooks, etc.). Knowledge of product comparability, target product profile and quality risk assessment activities Knowledge of basic analytical tools such as UV spectrophotometry and DLS particle sizing Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs) Soft Skills: Ability to work under minimal supervision and function within a collaborative, team-oriented environment Excellent organization and communication skills Ability to communicate and represent group in diverse, multi-functional meetings 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. 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 Equal Opportunity employers committed to a culturally inclusive 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. #GD-SA #LI-SA #vhd #LI-Onsite Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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. North America Applicants Only The salary range for this position is: $85.500,00 - $123.500,00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.