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.
Mark W. Honda – Director, Human Resources
Mark Honda joined ICOS Corporation, now CMC Biologics, in 2005, bringing more than 20 years of human resources experience to the company. In December 2007 he was named director, human resources. In this position, he is responsible for setting and implementing HR strategies and programs in the United States. Before joining CMC Biologics, Mark served in various HR management capacities at SNBL USA, Evergreen Healthcare, and the University of Washington Medical Centers. He holds a Bachelor of Science degree in Business Administration/HR Management from California State University, Northridge. He also possesses a Senior Human Resources Professional certification and Certified Compensation Professional (CCP) designation.
Bob Munday – Senior Director, Engineering Operations Support
Bob Munday joined CMC Biologics in December 2008 and currently serves as senior director of engineering operations support. In this position, he is responsible for engineering, environmental health and safety (EH&S), validation, capital projects, supply chain management, and global information technology. 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. 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.
Leland S. Paul, Ph.D. – Vice President, Process Development
Leland S. Paul, Ph.D., joined ICOS Corporation, now CMC Biologics, in 1995 as director of analytical and formulation development. In 2008 he was named vice president of process development. Lee has more than 27 years of experience in the biopharmaceutical industry, including stints at Bristol-Myers Squibb, Abbott Laboratories, and Codon, a start-up biotechnology company. His responsibilities have spanned all stages of biopharmaceutical development, from support of target discovery through product commercialization, with an emphasis on protein chemistry and protein physical characterization. He holds a Bachelor of Science degree in Chemistry from California Institute of Technology (Caltech) and a Ph.D. in Chemistry from the University of Oregon.
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. – Sr. Director, Manufacturing
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 of manufacturing at CMC Biologics. Prior to CMC Biologics, he was a research scientist at Sandia National Laboratories and a graduate research associate at the University of California, Berkeley. 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.