Christopher M. LeBlanc
Founder and Principal
Consultant of BioPharma Consulting Group, LLC
Christopher LeBlanc is the founder and Principal Consultant of BioPharma Consulting Group, LLC, a patient passionate, innovative consulting agency that provides quality services to the biotechnology, pharmaceutical and biologics industries.
He has over 15 years of industry experience in cGMP operations, quality control (QC), quality assurance (QA), systems, validation, and analytical development. He has held quality chemist and leadership positions at several pharma/biopharma companies. At the beginning of his career as an analytical chemist, Chris was involved with analytical method development and validation while working for Avatar Pharmaceutical Services, a start-up company at the time, and contract research organization (CRO).
The last 10+ years he has worked for large corporation start up sites including Lonza, a contract manufacturing organization (CMO) and Novartis in Singapore. He was responsible for and assisted with establishing quality control departments, leading quality control teams with method development, transfers, validations, new equipment qualifications, calibrations and validations, designing and overseeing QC sample management workflows, result release and sample disposition processes, quality systems implementation and management, setting up and executing stability programs, conducting internal audits and participating in external customer and regulatory audits.
At Lonza Singapore, Chris participated in frequent inspections/audits including on site customer and regulatory inspections by United States (FDA), Europe (EU), Japan, Brazil and Turkey. In addition, he contributed to the successful regulatory audits at Novartis Singapore which resulted in the granting of the sites GMP Manufacturing certificate by the Singapore Health and Sciences Authority (HSA), Singapore’s Regulatory Agency, and approval for manufacturing and distributing a commercial Drug Substance/Product to the European Union by the European Medicines Agency (EMA).
Chris holds a Bachelor of Science degree in Chemistry from Worcester State University, and a Master of Science degree in Analytical Chemistry from the University of Massachusetts.