Caroline Dugopolski, MS

Caroline Dugopolski brings 25 years of applied CMC, manufacturing, quality, and regulatory leadership to help biotech companies at every stage build therapies that are manufacturable, scalable, and compliant.  She specializes in translating complex science into phase‑appropriate CMC strategies, strengthening process control and quality systems, and identifying and mitigating the technical and operational risks that impede progress.  With deep expertise across biologics, cell and gene therapies, tissue‑engineered products, and AI‑enabled biomanufacturing, Caroline partners with clients to design robust development pathways, elevate quality maturity, prepare for regulatory engagement, and establish the technical and quality foundations required for successful development.  She holds an M.S. in Biomedical Engineering and a B.S.E. in Chemical Engineering from the University of Michigan.