Chris joined Biologics Consulting as a Senior Consultant in January 2015. He comes to Biologics Consulting with over twenty-five years’ experience in the development, manufacturing, and quality control of clinical and commercial biopharmaceutical products, as well as in vitro diagnostics. Since 2002 he has been a site head with primary responsibility for operational success, setting quality policy, and maintaining regulatory licenses for products and facilities. Since 1994 Chris has been leading teams in process improvement, technology transfer, quality improvement, facility design, CMC reviews, and validation of processes, equipment, and facilities. He has worked on 30 large-molecules (antibodies, vaccines, and peptides) and 10 small-molecules, from Phase I to Post-approval.
As VP of Operations at One Lambda, Inc. he improved manufacturing systems through process streamlining, enabling growth of sales and income more than 20% by reducing backorders 90% while doubling productivity. As VP of Pharmaceutical Operations at BioVascular, Inc. he managed a network of 12 external suppliers to bring two novel, first-in-class products to clinical trial and scaling up in preparation for Phase 2 studies. As Vice President and General Manager of Cambrex Bio Science Baltimore, Inc. he led a business turnaround to breakeven EBITDA after four straight years of loss by increasing revenues 35% and improving operational performance. In doubling the customer base and modifying the project costing algorithm, he helped position the business for acquisition and queued up a $4MM operating profit potential in 2007. During his tenure, the company passed US and EU PAIs for Tercica’s Increlex®, with no 483 and no major observations, respectively. Prior to Cambrex, Dr. Bussineau held increasingly responsible positions at Chiron Corporation, starting as Scientist and ending as Senior Director of Technical Operations, where he was responsible for management of up to 4 cGMP manufacturing facilities, one of which involved the development of its first low-cost, multiproduct plant in Vacaville, CA.
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. He is a detail-oriented, data-driven, hands-on professional that enjoys solving challenging technical problems faced by small and large pharmaceutical companies and understands how to use the quality system to drive business success. For example, he is particularly keen about engaging staff in assessment, analysis, and remediation of issues that impede operational performance.
PhD, Chemical Engineering, Rice University, Houston, TX (1986)
BA, Chemistry (Biochemistry emphasis), University of California, San Diego, CA (1977)