Michelle Andraza serves as EXUMA’s Director, Quality Assurance & CMC and has been with the company since April 2018. Ms. Andraza is responsible for oversight of the CMC team with development and implementation of manufacturing strategies for EXUMA’s CAR-T Cell Therapy products, operation and management of the Global QMS, and collaboration on regulatory and pre-clinical projects to support clinical development. Prior to joining EXUMA Biotechnology, Michelle was the lead QA/RA project manager at Ironshore Pharmaceuticals & Development, Inc. where she led the cross functional CMC team through preparation, strategy, submission and maintenance of 3 INDs and 1 NDA, as well as an on-site sponsor inspection with the US Food & Drug Administration while maintaining the internal QMS and managing Clinical TMFs. Michelle completed an Honors BSc with a major in Molecular Biology and Genetics in 2011 from the University of Guelph in Ontario, Canada and completed the Regulatory Affairs and Quality Operations Program at Seneca College in Toronto, Ontario, Canada in 2015 shortly before relocating to Grand Cayman, Cayman Islands.
Michelle AndrazaDirector, Quality Assurance & CMC