Amy Hardwick, MSRSc, RAC-Devices

Amy Hardwick is a Technical (CMC) Regulatory Program Director at Roche/Genentech. She supports regulatory aspects of biospecimen, genomics, and bioinformatics workflows to enable Roche/Genentech’s individualized neoantigen specific immunotherapy (iNeST) portfolio. She has a wide range of experience in both pharma/biotech and medical devices/IVDs, including CMC regulatory filings, regulatory compliance, and change management. Amy received her Master's degree in Regulatory Science cum laude from USC, and her B.S. degree in Chemistry cum laude from Ball State University. She also holds a Regulatory Affairs Certification (RAC) in Medical Devices.