AspireBio Consulting
Isabel Cruz is an experienced consultant in quality control (QC) and biostatistical analysis at AspireBio Consulting since February 2023, specializing in CMC technical and regulatory strategy for biotherapeutics. Prior to this role, Isabel served as an Associate Scientist in Quality Control at Turnstone Biologics, managing stability programs for Virus Immunotherapy and supporting TIL immunotherapy studies with a strong focus on statistical analysis and compliance with regulatory standards. Earlier experience includes roles as an R&D Scientist, Reliability Engineer, and Stability Technician at Abbott Point of Care Canada Limited, contributing to the launch of innovative medical devices and conducting extensive stability studies. Isabel's academic background includes an M.Sc. in Biology from Carleton University and a B.Sc. in Pharmacy-Biochemistry from USP - Universidade de São Paulo.
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AspireBio Consulting
AspireBio Consulting has a proven track record in helping move products from early development to commercial. Deep expertise in pre-clinical/non-clinical, CMC, quality, regulatory and FDA, Health Canada and EMA compliance for manufacturing and product release.