An accomplished biotechnology professional with over 30 years of experience in development, technical operations, quality systems and regulatory affairs for complex biologicals. For the past 25 years he has held executive level positions designing, implementing and operating the CMC and GMP manufacturing infrastructure for various pioneering cell and gene therapy companies, including Orchard Therapeutics, Sangamo Therapeutics, StemCells Inc., PCT Cell Therapy Services, Xcyte Therapies, Osiris Therapeutics, and SyStemix, Inc.
In his career he has successfully led the development, manufacture and clinical delivery of recombinant proteins, monoclonal antibodies, hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), neural stem cells (NSCs), activated T cells, gene-modified T cells & gene-modified HSC products, as well as adeno-associated virus (AAV), gamma-retroviral (gRV) and lentiviral (LV) vector products.
Stewart also has extensive experience in business development and the successful management of regulatory affairs for cell and gene therapy submissions in US, Canada, Switzerland and Europe
