Consulting support for early-stage biologics programs: Module 3 (IND/IMPD), process & analytical development, QbD, process descriptions, comparability, specifications, reference standards, risk assessments, validation, SOPs, batch records, and technical strategy documents
About
PhD in Engineering and Medical Science from the University of Calgary with 20+ years of biologics and vaccine development experience. Expertise includes mRNA-LNP therapeutics, live viral vectors, monoclonal antibodies, recombinant proteins from mammalian, baculovirus, and bacterial systems, plasmid DNA, and diagnostics. Former VP of Process and Analytical Development at Providence Therapeutics, Senior Director/Director at Sanofi Pasteur, and Head of R&D at Syn-X Pharma/Nanogen Diagnostics. Led CMC development for ~20 vaccine and therapeutic candidates from discovery through GMP manufacturing and clinical supply. Experienced in process, formulation, analytical, and regulatory development, Module 3 authoring, QA/RA oversight, technology transfer, and management of CDMOs and CTLs.
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