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Derek Hei
Chief of Manufacturing and Technical Operations at BlueRock Therapeutics, USA


Derek has over 25 years of experience developing breakthrough cell and gene therapies from research through clinical trials. He has distinct expertise in current Good Manufacturing Practices (cGMP) compliance, manufacturing, quality control testing and regulatory compliance for biologics including cell and gene therapies. At BlueRock, Derek currently oversees the entire clinical manufacturing function, which includes developing and producing BlueRock’s induced pluripotent stem cell platform, maintaining its state-of-the-art cleanroom facility and cGMP Quality System, and leading the CMC regulatory efforts for submitting investigational new drug applications. Derek previously served as vice president of clinical manufacture, quality and regulatory at Cellular Dynamics International, where he oversaw the development and production of its cell therapy products. Prior, Derek served at Waisman Biomanufacturing, Cerus Corp and Genentech. Derek obtained his B.S. in chemical engineering from the University of Wisconsin-Madison, and his Ph.D. in biochemical engineering from the University of California, Berkeley.

Agenda Sessions

  • Raw Materials/Starting Materials