Duties/Responsibilities The incumbent serves as the Division Director of the Division of Human Tissue (DHT) within the Office of Cellular Therapy and Human Tissue CMC (OCTHT) under the Office of Therapeutic Products (OTP) and manages daily operations of the Division. This position reports to the Director of OCTHT. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other products regulated by OTP. DHT is responsible for the interpretation of existing regulations and guidance regarding human cells, tissues, or cellular or tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion or transfer into a hu
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