Speaker Profile

Herman F. Bozenhardt

Principal, Bozenhardt Consulting Services LLC

Mr. Bozenhardt has 37 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies.

Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems, with service to Novo Nordisk, DSM, Catalent, Organon Teknika, Bausch and Lomb, Alcon, J&J, Bristol Myers Squibb, Janssen Pharmaceuticals, as well as operations positions within Pfizer Inc.

Mr. Bozenhardt has extensive experience in the manufacturing therapeutic biologicals and vaccines via cell culture technology, human plasma derivation and egg based technologies.

Prior to being an executive consultant, Mr. Bozenhardt was an engineering executive with Life Sciences International, Foster Wheeler, Aker Kvaerner, and KBR.

Mr. Bozenhardt has a BS Chemical Engineering and MS System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).



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Biological Facility Design for Compliance

The field of biological facility design has been one of the most evolving engineering practices over the last 30 years. In the 1980s most biological facilities were modeled after generations of antibiotic production. These were large and suffered with significant bioburden problems.

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