Mark F. Witcher, PhD

Exyte Management GmbH
BioPharm Operations SME
Mark is currently publishing articles based on his 35+ year of experience in biopharmaceutical, pharmaceutical and medical devices. Prior to semi-retirement, Mark was a member of NNE’s Strategic Manufacturing Concept Group after working at IPS on feasibility and conceptual design studies for advanced biopharmaceutical manufacturing facilities. Before working for engineering companies, Mark, while helping raise his two kids, was an independent consultant in the biopharmaceutical industry for 15 years on operational issues related to: Process development, product development; strategic business development; clinical and commercial manufacturing planning; tech transfer; and facility design and construction. For many years, he taught an ISPE Biopharmaceutical Process Validation course. He was previously the Sr. Vice President, Manufacturing Operations for a CMO Covance Biotechnology Services (formerly Corning Bio, Inc.). At Covance, he was responsible for the design, construction, start-up, and operation of Covance's $50MM contract manufacturing facility. Prior to joining Covance in 1995, he was Vice President of Manufacturing at Amgen, Inc. Mark was with Amgen for nine years and held positions as Engineering Manager, Plant Manager, and Director of EPOGEN® Manufacturing. Mark received his Ph.D. in Chemical Engineering from the University of Massachusetts.