Waisman Biomanufacturing Leadership
Derek Hei is the Director of Waisman Biomanufacturing. Dr. Hei has a Ph.D. in Chemical Engineering from the Universityof California- Berkeley and has over 15 years of experience in industry developing processes for manufacturing biologics and medical devices for use in human clinical trials. Dr. Hei previously served as the Director of Biomedical Engineering at Cerus Corp. (Concord, CA) where he led a team of scientists and engineers that were involved in developing systems and medical devices for processing cell-based therapeutics. Prior to Cerus, he worked in the Process Recovery R&D Group at Genentech (South San Francisco, CA). There he was involved in the development of purification processes and analytical methods for protein therapeutics. Dr. Hei oversees a team of scientists with extensive experience in current Good Manufacturing Practices and Good Tissue Practice. Dr. Hei currently serves as Principle Investigator of the NIH funded Product Assistance for Cellular Therapy (PACT) Program. In addition, he has served as PI and co-PI on other NIH-funded clinical manufacturing projects, including the National Stem Cell Bank. Dr. Hei serves as a scientific and management lead for all cGMP manufacturing and banking activities.
John Welp is the Manager of Operations for Waisman Biomanufacturing. Mr. Welp has a B.S. and an M.S. in Chemical Engineering from Rose-Hulman Institute of Technology and over 20 years of experience in industry developing manufacturing processes for biotherapeutics. Mr. Welp previously served as the Director of Process Development at Powderject Vaccines (Madison, WI) and Director of Integrated Manufacturing at GeneMedicine Inc. (Woodlands, TX) where he was primarily involved in the development of manufacturing processes for DNA vaccines and plasmid DNA gene therapeutics. Mr. Welp is primarily responsible for coordinating the activities of manufacturing personnel and ensuring that the equipment and facility are maintained, calibrated, validated and monitored according to WCBF Standard Operating Policies and cGMP guidelines.
Tim Sparks joined Waisman Biomanufacturing in September 2004 as Manager of Quality Assurance. Mr. Sparks received his B.S. in Biology with a minor in Chemistry from the University of Wisconsin - Whitewater in 1980 and an M.S. in Management from Cardinal Stritch University in 1998. He has over twenty years of experience in Quality working for Abbott Diagnostics Division (Abbott Park, IL) and Pel-Freez Clinical Systems (Brown Deer, WI). In his previous positions at Abbott Diagnostics Division, Mr. Sparks served as a Quality Manager and Quality Supervisor and was responsible for maintaining quality records and standard operating procedures, assuring adherence to corporate quality system requirements, supporting validation efforts, and conducting internal and external audits. His primary area of responsibility within the WCBF is supervision of Quality Assurance and Quality Control. He is also responsible for overseeing the Quality System, batch record review, and release of final product from Waisman.
Ross O. Meyers, Ph.D. is the Manager of Quality Control at Waisman Biomanufacturing. Dr. Meyers has a Ph.D. from the University of Arizona, CALS and the Arizona Cancer Center Tucson, AZ. His foundations of study are in Cancer Chemotherapeutics, Medicinal Chemistry and Pharmacology. His early research was at Rush University, Chicago, IL in protein structure-function studies and related mechanisms of arthritic cartilage damage. He joined the Arizona Cancer Center Therapeutic Development Program in 1993 where he researched chemotherapeutics; including pharmacokinetics, pharmacologic mechanism of action studies and related bioanalytical method development. He led a group of scientists in analytical R&D for the validation of biopharmaceutical methods at the PPD GMP labs, Madison, WI from 2006 to 2011. He joined Waisman Biomanufacturing in June of 2011. He leads a group supporting cGMP quantitative and qualitative QC testing and methods development for manufactured products. The Quality Control group is responsible for the execution and management of in-house and out-sourced QC testing, documentation, data review and approval. The QC group manages and maintains cleanroom environmental monitoring.