Anna Gilbert BDO

Anna has over twenty years of experience in Quality Assurance (QA) and Quality Control (QC) in Biotechnology, with the last ten years focused on cell and gene therapy. Anna has provided compliance and program oversight in the protein world, ranging from cell banking to bulk product, filled product, and testing. Also, she offered compliance support to programs such as computer systems validation, raw materials, specification development, and stability. In the cell and gene therapy realm, Anna has compliance experience with apheresis collections and shipment, cord blood units, viral vectors (gamma and lenti), ancillary materials, and finished cell therapy product. She has extensive experience in inspection readiness and inspection management.

Before joining BDO, Anna was Senior Director of QA and QC at Nohla Therapeutics which developed an allogeneic stem cell product. Before Nohla Therapeutics, she was one of the earliest employees and the first in Quality Assurance at Juno Therapeutics. While there, Anna established the first quality systems and managed the GMP quality compliance program. In 2009, she joined Dendreon and managed all aspects of GMP and GTP quality compliance, including internal and external auditing as well as compliance oversight of apheresis sites. She participated in the successful pre-approval inspection of the first US commercial cell therapy, Provenge. Before moving into cell therapy, Anna worked on proteins at several firms, including Amgen, Immunex, and Chiron.

Anna is an ASQ Certified Quality Auditor and a member of the Parenteral Drug Association (PDA). She delivers annual lectures on the topics of quality systems and auditing at the University of Washington’s Master of Science in Biomedical Regulatory Affairs program. Anna earned her BS in Marine Biology and Chemistry from Western Washington University.