Areas of expertise: Product Pipeline, GMP/QMS, Analytical and Process Development, Biologics, Medical Devices
Current role: Principal Consultant at AspireBio and, R&D Operations Lead at Vital Bio
Sam Sathiamoorthy has built deep expertise in vaccinology, therapeutics, and medical devices over the last 15 years in big pharma, biotech start-ups and early-stage proof-of-concept environments. She holds a PhD in Cellular and Molecular Biology from the University of Guelph and has vast technical expertise in immuno-oncology, cell and gene therapy, vaccines, biotherapeutics and IVD. Her experience extends to GMP manufacturing and FDA, Health Canada and EMA compliance for manufacturing and product release. She is proficient in technical, medical and regulatory writing and has provided regulatory strategy for both IND and CTA submissions.