Maik  Jornitz Author of Evaluating Organization Development

Maik Jornitz

BioProcess Resources LLC

Maik W. Jornitz is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 11 books, 18 book chapters and over 100 scientific papers. He is member of multiple PDA Task Forces, former Chair of the Board and Science Advisory Board.


Maik W. Jornitz is founder and principal of BioProcess Resources LLC. Jornitz has close to 35 years of experience in separation, filtration and single-use process technologies, process and facility designs, respectively the related regulations and validation requirements. His subject matter expertise in sterilizing grade filtration supports regulators as much as the industry. His vision in new cleanroom structures, required for the biopharmaceutical and cell/gene therapy processes, will transform the industry to faster, more flexible and less expensive facility solutions. As a former member of the Parenteral Drug Association (PDA) Director of the Board (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, 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 and is faculty member of PDA TRI and Global Compliance. Jornitz authored and co-authored over 100 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) and integrity testing. He received 5 distinguished author awards, 2 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 ten influencer. He formerly worked for Sartorius Stedim in various positions for over 25 years, is Science Advisory Board member of Interphex and ICAV and member of the Biotechnology Industry Council. 
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.



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