- Describe typical manufacturing processes of Upstream, Separation, Downstream, and Purification
- Describe the basic functions of the Unit Operation (UO) including the processes
- Identify the typical sequence of Unit Operations required and how they are connected
- Provide a basic lexicon of biopharmaceutical processes
Mark Witcher, Ph.D is a Senior Consultant for IPS - Integrated Project Services in Morrisville, NC. At IPS, Mark does feasibility and concept process designs and operational plan development for novel and advanced facility designs. Prior to joining IPS in 2011, he was a 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. He teaches courses on process validation for ISPE. He was previously the Sr. Vice President, Manufacturing Operations for 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 for Amgen, Inc. Mark was with Amgen for nine years and also 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.