Barry Rosenblatt, Ph.D., President, SME Biotech Consulting; is a subject matter expert in the chemistry and manufacturing controls (CMC) of biotherapeutics with a proven 30+ year track record in biotechnology and the pharmaceutical industry. Developed, transferred, and validated purification processes and assays for multiple new molecular entities through all stages of drug development, including licensure. Currently serving as a consultant to the industry as President/sole proprietor of SME Biotech Consulting. The proven presenter who has served as an instructor, presenter, as well as Chairperson for conferences and courses. Previously served as associate director of Process Development for Centocor/JNJ (18 years) and 8 years as head of Analytics, Process Evaluation, Contract Manufacturing, and Sterile Services at Charles River Laboratories, Malvern PA... Academic credentials include a Ph.D. in Cell Biology/Immunology from the Albert Einstein College of Medicine, Bronx, NY.