Dr. Chang brings to Raven more than 15 years of experience in taking protein therapeutics from the preclinical research stage through production for clinical trials, with specific expertise in commercial scale-up of biopharmaceutical manufacturing facilities, process development and optimization, quality assurance and quality control, Good Laboratory Practices and Good Manufacturing Practices compliance and oversight, analytical methods development, regulatory submissions, and management of preclinical, clinical, production, and contract manufacturing and testing. Dr. Chang has worked on more than 20 preclinical and clinical drug development projects and numerous regulatory submissions. Prior to joining Raven, she was Vice President of Operations at GeneTrol Biotherapeutics, Inc. Her previous positions include Senior Director of Quality Systems and Analytical Development at Coulter Pharmaceutical, Inc., Director of Quality Control at SyStemix, Inc., and Manager of the BioProcess Control Virology Laboratory at XOMA Corp. Dr. Chang received a PhD in Microbiology from the University of California, Davis and a BA in Biochemistry from the University of California, Berkeley. |