Maik W. Jornitz

Maik W. Jornitz is the Principal Consultant and Founder of Bioprocess Resources LLC. Jornitz has close to 40 years of experience in separation, filtration and single-use process technologies, process and facility designs, respectively the related regulations and validation requirements. As a former member of the Parenteral Drug Association (PDA) Board of Directors (former Chair of the Board of Directors) and former Chair of the Science Advisory Board (SAB), Jornitz has been part of multiple PDA task forces, for example the Technical Report # 26, #40, #41, #45, PAC-iM, mycoplasma task forces, and conference program co-chair for the 2008, 2013 and 2016 Annual Meeting and co-chair of the Aging Facility Task Force. He is also member of the ISPE, ASTM E55 working group, is Science Advisory Board member of Interphex and ICAV and member of the Biotechnology Industry Council. As faculty member of PDA TRI and Global Compliance he lectures on sterile filtration, new process and facility technologies. Jornitz authored and co-authored over 130 scientific papers. He is co-editor and -author of 11 books for example Filtration and Purification in the Biopharmaceutical Industry, Sterile Filtration – A Practical Approach and Pharmaceutical Filtration. He has contributed in total 15 chapters to various technical books, including the Encyclopedia of Pharmaceutical Technology. He holds over 30 patents related to biopharmaceutical process equipment (single-use technology), integrity testing and prefabrication components. He received five distinguished author awards, two PDA Special Service, the Michael S. Korczynski, J. Agalocco, F. Carlton, Martin Van Trieste and Honorary Member award and has been three times a Medicine Maker top industry influencer. He formerly worked for Sartorius Stedim in various positions for over 25 years and the CEO of G-CON Manufacturing Inc. Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.