Onesmo Mpanju, PhD is a Principal Consultant with Linq Pharma Consulting, Inc., a Virginia-based firm specializing in biopharmaceutical R&D and regulatory affairs. Previously, Onesmo served as a Chemistry, Manufacturing, and Control (CMC) Reviewer at the U.S. FDA, Center for Biologics Evaluation & Research. From 2006 to 2014, he held various leadership positions with a global contract research organization (CRO) in the United States and China, and from 2014 to 2017, he consulted for biopharma companies in South Korea and internationally. His consulting experience also includes work with non-commercial entities such as the U.S. National Institutes of Health, the Department of Defense, the Bill & Melinda Gates Foundation, UK Public Health Agency.

Onesmo has guided multiple teams in developing regulatory submission strategies and quality programs for several products including novel recombinant DNA products, biosimilars, new chemical entities, vaccines, and cellular and gene therapies. His expertise also extends to conducting quality due diligence audits for asset acquisition, internal cGMP and GCP compliance audits, and managing clinical trial authorizations and marketing submissions to agencies in the US, Canada, EU, UK, China, Republic of Korea, Kenya, and Tanzania.

Onesmo holds a Ph.D. in Experimental Medicine with a focus on Infectious Diseases from the University of British Columbia, Vancouver, Canada. He is a respected figure in the industry, known for his public presentations at scientific and industry events, as well as his contributions to peer-reviewed journals.