Christopher Bussineau, PhD

Christopher Bussineau, PhD

Senior Consultant

Chris joined BC as a Senior Consultant in 2015 after two 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. 14 of those years were in plant 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 has supported no less than 40 large-molecules (antibodies, vaccines, and peptides), 6 gene therapy products, 5 live biotherapeutic products, and 10 small molecule APIs bridging Pre-clinical development to Post-approval lifecycle management. His authoring at BC alone includes 22 IND/IMPDs, 8 BLAs, 2 Type V Master Files, a 510(k), and 12 formal FDA meeting background packages.

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 on the Biotechnology Advisory Board.

His expertise and interests include technology transfer; facility and process engineering design; process development; technical troubleshooting; cell substrate, drug substance, and drug product characterization; annual production reviews; due diligence; supply chain analysis; microbiology support; manufacturing oversight (man-in-plant); quality systems support; risk management; FMEA; training; operations strategy; operational excellence; validation of cleaning, equipment, process, and software; vendor qualification and audits; regulatory submissions support for your Annual Report, IND, NDA, ANDA, BLA, IMPD, MAA, and 510K; formal FDA meeting requests and briefing documents; supplier and GMP audits; mock pre-approval inspection auditing; CAPA and deviation investigation and resolution; vaccines; blood products; cell and gene therapy; recombinant proteins; monoclonal antibodies; live biotherapeutic products; oligonucleotide products, small molecule APIs; and human microbiome products.


Education

PhD, Chemical Engineering, Rice University, Houston, TX (1986)

BA, Chemistry (Biochemistry emphasis), University of California, San Diego, CA (1977)