Christopher M. Bussineau, PhD Biologics Consulting Group Inc.

Chris has over thirty years experience in the development, manufacturing, and quality control of clinical and commercial biopharmaceutical products, as well as in vitro diagnostics. He led teams in process improvement, technology transfer, manufacturing, quality improvement, facility design, CMC reviews, and validation of processes, equipment, and facilities. As a site head, he had responsibility for operational success, quality policy, and maintaining regulatory licenses. He has worked on 30 large-molecules (antibodies, vaccines, and peptides) and 10 small-molecules, from Preclinical to Phase IV. Since joining PDA in 2001 he has contributed to the Biotech Advisory Board, the Biotech Interest Group, and many Task Forces with fondest memories of getting TR42 published. Chris holds a PhD in Chemical Engineering from William Marsh Rice University and a BA in Chemistry with emphasis in Biochemistry from the University of California at San Diego.