About Us
Our mission is to provide a world class facility and service for the development of leading-edge biotechnology.
ThermoGenesis has over 35 years in the biotechnology industry and currently maintains an FDA registered manufacturing facility at its main office in Rancho Cordova, CA. Over the years, ThermoGenesis has been audited regularly by the FDA, EU (MDSAP), EU-MDR, TUV, as well as customer audits. ThermoGenesis has never failed an audit. Because of our strong Quality Management Systems and commitment to Quality, ThermoGenesis is uniquely qualified to operate and maintain a cGMP facility.
The ThermoGenesis staff loves to share! We will leverage our in-house experience and expertise to provide support to the client as part of the service. Support services include Quality Management, Scientific Affairs, Regulatory Affairs, Engineering, and Business Operations.
Our Staff
Haihong Zhu / President
Haihong Zhu has over 25 year of technical, research and development, and marketing experience in stem cell and cell therapy industry. Haihong started her career in stem cell research at Harvard Medical School, then moved to BioTransplant Inc. She joined ThermoGenesis in 2004 and helped develop and market an automated cell processing technology for cell banking and cell-based therapies. She is currently a Director of the Board, and President & Chief Operating Officer at ThermoGenesis Holdings Inc (Nasdaq:THMO).
Ms. Zhu graduated from the Shanghai University of Science & Technology with a Bachelor’s in Biology and also studied statistics at Boston University.
Darrell Drysen / VP Operations
Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.
Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.
Jason Le / VP Regulatory Affairs
Jason Le, Vice President, Quality Assurance and Regulatory Affairs, joined ThermoGenesis in 2012. Jason brings over 26 years of experience in Quality Assurance from start up to established worldwide companies including Medtronic, Hologic. Jason developed and manages all aspects of the Quality Management System that are in compliance with QSR 21 CFR 820, QSR 21 CFR 1217, ISO 13485:2016, MDSAP and transitioning to EUMDR. He leads all FDA, ISO, notified body, supplier, internal and customer audits. Jason’s lends his expertise in Quality Management and Regulatory Affairs to new product development projects and successful management of post market customer feedback programs.
Ryan Scally / Senior Facilities Manager
Ryan brings over 10 years of Quality Assurance, EH&S, and Facilities experience and expertise to the ReadyStart Team. Ryan is trained and certified in DoT Regulated Waste Removal, Bloodborne Pathogens, electrical safety, and fire safety. Ryan joined Thermogenesis in 2019 as part of the Quality Assurance Team and has since been an integral part of QA Inspections, Document Control, Project Teams, Facilities, and EH&S.
Service Area
ReadyStart CleanRooms is a division of ThermoGenesis Holdings Inc. and is headquartered in Rancho Cordova, California. We serve the Northern California Region including Sacramento, Elk Grove, Roseville, Folsom, Davis, Woodland, Citrus Heights, Rocklin, West Sacramento, Auburn, Lincoln, San Francisco, Oakland, San Jose, Berkeley, Palo Alto, Mountain View, Sunnyvale, Santa Clara, Redwood City, Menlo Park, Cupertino, Fremont, Hayward, San Mateo, Concord, Vallejo, Fairfield, Richmond, Daly City, San Rafael, Petaluma, Novato, Santa Rosa, Napa, Livermore, Pleasanton, Walnut Creek, Alameda, San Leandro, and San Ramon.