Sean Smith
About Sean Smith
Sean Smith serves as the Supervisor of Manufacturing for Cell Therapy at ElevateBio, where he has worked since 2020. With over 13 years of experience in Good Manufacturing Practices, he has a strong background in clinical trials and regulatory standards.
Work at ElevateBio
Sean Smith has been serving as Supervisor of Manufacturing for Cell Therapy at ElevateBio since 2020. He is based in Waltham, Massachusetts, and has accumulated four years of experience in this role. His responsibilities include overseeing the manufacturing processes involved in cell therapy, ensuring adherence to industry standards and regulations.
Previous Experience at Dana-Farber Cancer Institute
Before joining ElevateBio, Sean Smith worked at Dana-Farber Cancer Institute for a total of seven years. He held various positions, starting as a Material Management and Logistics Technician from 2009 to 2013. He then progressed to Cell Processing Specialist roles, serving as Specialist II from 2016 to 2019 and Specialist III from 2019 to 2020. His experience at Dana-Farber provided him with a solid foundation in cell processing and manufacturing.
Education and Expertise
Sean Smith earned a Bachelor’s Degree in General Biology from the University of Massachusetts Boston, completing his studies from 1999 to 2004. He has over 13 years of experience in current Good Manufacturing Practices (cGMP) and possesses a strong understanding of regulatory standards, including HIPAA, FACT, and FDA guidelines related to human cellular therapy products.
Project Management Experience
Sean Smith has project management experience specifically related to clinical trials. His role involves proactively identifying opportunities for improvements in process, safety, quality, and cost within the manufacturing environment. He collaborates effectively with cross-functional teams, including process sciences, development, and quality assurance, to facilitate successful technology transfer for scalable cell therapy manufacturing processes.