Mark W. Sawicki, Ph.D. – Global Vice President, Business Development
Mark Sawicki joined CMC Biologics in 2012 as the global vice president, business development. He has nearly 15 years experience with biotechnology, contract research, and manufacturing companies. Prior to CMC Biologics, he was the vice president of business development, Europe at AMRI. Mark has more than a dozen peer reviewed publications as well as dozens of invited speaking engagements at conferences. Mark holds a Bachelors and Doctorate in Biochemistry from the University at Buffalo.
Stephen W. Hadley, Ph.D. – Vice President, Quality
Stephen W. Hadley, Ph.D., joined ICOS Corporation, now CMC Biologics, in 1995. He is currently vice president of quality and is responsible for oversight of the quality assurance, quality control cGMP, and analytical/formulation development activities for the Company. Prior to CMC Biologics, Steve was a research scientist with the U.S. Food and Drug Administration (FDA), where he was responsible for evaluating analytical methods for regulatory actions and for performing preapproval inspections of biotechnology companies. He was a founding member of the Pacific Region Biotech Inspection Team (a predecessor to FDA Team Biologics). He also held research scientist positions in discovery research and quality control at NeoRx Corporation (now Poniard Pharmaceuticals). Steve received his Bachelor of Science degree in Organic Chemistry from the University of Maine and his Ph.D. in Organic Chemistry from the University of Washington.
Bob Munday – Vice President, Technical Operations
Bob Munday joined CMC Biologics in December 2008 and currently serves as Vice President Technical Operations. In this position, he is responsible for Manufacturing, Engineering, Environmental Health and Safety (EH&S), Validation, site Continuous Improvement, Capital Projects, Supply Chain Management (SCM), and Global Information Technology (IT). Prior to joining CMC Biologics, Bob was Director of Production Support at Novo Nordisk Pharmaceutical Ind., Inc. (an insulin fill/finish facility), where he led a staff of more than 100 employees. During Bob’s career at Novo Nordisk, he supported / led capital expansion projects in the continental United States, Europe and Asia. Bob has over 20 years’ experience in Project Management and Operations. He received his Project Management Professional (PMP) certification in 2006.
Mats Nygren – Vice President, Finance
Mats Nygren joined CMC Biologics in 2011 as vice president, finance. He has nearly 20 years experience with high technology, medical, and manufacturing companies. Prior to CMC Biologics, he held financial management positions at Precor and Physio-Control (a division of Medtronic). He also spent six years at Medtronic Corporate in Cardiac Rhythm Management, where he analyzed markets and developed pricing strategies and launch tactics for a line of cardiac products. Mats holds a Master of Business Administration in Finance and International Business and a Bachelor of Arts degree in Economics and German from the University of Michigan.
Susan E. Sullivan – Vice President, CMC Project Management
Susan Sullivan is vice president, CMC project management for CMC Biologics. In 2001, she joined ICOS Corporation, which later became CMC Biologics, to establish CMC project management practices for the transfer of a Phase III clinical product to commercial bulk drug substance and drug product manufacturers. She also served as the project manager for numerous antibody and protein campaigns where the Company served as the contract manufacturing organization. Susan has been in the industry for more than 16 years. Susan’s prior experience includes Intracel Corporation, where as director of manufacturing she was responsible for the manufacturing of FDA-approved and regulated antibody-based products for infectious diseases. She also held positions as production manager and senior scientist at Aprogenex, where she managed the design, development, and production of DNA/RNA probes for the detection of genetic abnormalities and infectious diseases. She received a Bachelor of Arts degree in Zoology from the University of Texas at Austin.
Andy W. Walker, Ph.D. – Vice President, Process Development
Andy W. Walker, Ph.D., started at ICOS Corporation, which later became CMC Biologics, in 2003 as a scientist and has held positions of increasing responsibility in development and manufacturing since then. In 2010, he assumed the role of senior director and head of manufacturing at CMC Biologics in Seattle. As the head of manufacturing he led the operational start-up of CMC’s Production Facility 1 after its construction and Production Facility 2 after its renovation. In 2012 Andy returned to the Process Development organization as Vice President of Process Development. Prior to CMC Biologics, he was a research scientist at Sandia National Laboratories. Andy has a Bachelor of Science degree in Chemical Engineering from the University of Washington and a Ph.D. in Chemical Engineering and a Management of Technology certificate from the University of California, Berkeley.