I’m excited to share a look at my journey leading GMP manufacturing, quality operations, and CMC strategy across biologics, cell and gene therapies, and vaccines—from facility design and C&Q to IND/BLA submissions and commercial readiness. My path has been about building strong teams, scaling robust processes, and aligning science with compliance to deliver therapies that matter. Here is my biography.

Dr. Heather E. Stefanski, MD, PhD, is a leading authority in pediatric hematology, stem cell transplantation, and cell therapy innovation. As Executive Vice President of CIBMTR and Clinical Services at the National Marrow Donor Program (NMDP), she drives national and global initiatives focused on donor safety, transplant access, and cellular therapy advancement. With over 65 peer-reviewed publications and multiple patents, Dr. Stefanski blends clinical excellence with groundbreaking research to improve outcomes for patients worldwide. She serves in key leadership roles across the WMDA, ASH, and ASTCT, and is recognized for her visionary contributions to donor health and translational medicine.