As VP of Quality at Just, Donna is responsible for building and managing efficient and phase appropriate quality systems. Donna brings more than 30 years of experience in biotechnology disciplines, including biologics manufacturing, diagnostics, medical devices, and advanced cellular therapies.
Donna has held numerous Director level roles in Quality Control, Quality Assurance, and Regulatory Affairs. Most recently, Donna served at Dendreon where she supported QA, QC, Operations, and the pre-approval inspection for the first FDA licensed cellular therapy Provenge. Prior to Dendreon, Donna led the QC group at Immunex through the FDA inspection and commercialization of Leukine®. Donna began her career in QC at Genetic Systems with the commercialization of the first HIV blood screening test. Throughout the course of her career, Donna has been actively involved in regulatory inspections, contract manufacturing, pre-approval inspections, and the advancement of numerous products from clinical programs to commercial products.