Christopher Bussineau | Principal Consultant
Biologics Consulting Group, Inc.

Christopher Bussineau, Principal Consultant, Biologics Consulting Group, Inc.

Chris joined Biologics Consulting as a Senior Consultant in 2015 after 2 years as an independent CMC consultant and more than 25 years of experience in the development, manufacturing, and quality control of clinical and commercial biopharmaceutical products, as well as IVDs. Fourteen of those years involved site management with primary responsibility for operational success and maintaining regulatory licenses. Since 1994 Chris has been leading teams in process improvement, technology transfer, quality improvement, facility design, and validation. He supports monoclonal antibodies, bispecifics, ADCs, vaccines, peptides, cell and gene therapies, live biotherapeutic products, oligonucleotides, blood products,  as well as small molecule APIs. His work bridges pre-clinical development to post-approval lifecycle management and consists primarily of regulatory submissions support, technical troubleshooting, supply chain analysis, manufacturing oversight (man-in-plant), quality systems support, risk management, FMEA, training, process validation, due diligence, and auditing.
 
Prior roles include VP of Operations at One Lambda, Inc., VP of Pharmaceutical Operations at BioVascular, Inc., Vice President and General Manager of Cambrex BioScience Baltimore, Inc., and Senior Director of Technical Operations at Chiron Corporation. He holds a PhD in Chemical Engineering from William Marsh Rice University and a BA in Chemistry from the University of California at San Diego. Active with the Parenteral Drug Association since 2001, he contributed to Technical Reports #42, #14, and #15, and was a member of the Biotechnology Advisory Board.

Appearances:



Day 2 - Wednesday 30th October @ 14:15

Navigating CMC Challenges in Current Vaccine Development

last published: 10/Jul/24 14:15 GMT

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