President, Full-Time Pharmaceutical Development Consultant
CurrentWith 20+ years of hands-on experience in small molecule CMC development, I assist drug developers with the management of the Chemistry, Manufacturing, and Controls aspects of drug development, from pre-clinical development of small molecules and peptides, to formulation development, clinical manufacturing, and scale-up. Clients typically use me as their virtual VP/Director/Project Manager of Manufacturing & Development, whereby I organize, coordinate and execute comprehensive drug development… Show more With 20+ years of hands-on experience in small molecule CMC development, I assist drug developers with the management of the Chemistry, Manufacturing, and Controls aspects of drug development, from pre-clinical development of small molecules and peptides, to formulation development, clinical manufacturing, and scale-up. Clients typically use me as their virtual VP/Director/Project Manager of Manufacturing & Development, whereby I organize, coordinate and execute comprehensive drug development plans on behalf of my clients.I specialize in synthetic organic chemistry, small molecules (chiral and achiral drugs), peptides, peptidomimetics, solid dosage form, and intranasal (powder) delivery. I am trained in organic synthesis, peptide synthesis, cGMP manufacturing, and CMC writing for INDs.Examples of where I typically offer assistance: Pre-IND meeting requests, authoring of CMC sections and documentation for regulatory submission, qualification and management of CDMOs, oversight of cGMP manufacturing activities, establishment of API and drug product specifications, authoring and review of batch records, review of non-conformance reports, analytical method development and validation, control and stability of drug product and drug substance, powder characterization (particle size, hygroscopicity, powder flow properties, thermal behaviour, XRPD, solubility, plume geometry, spray pattern), impurity characterization and synthesis, solid oral dosage forms, tech transfer, CMC gap analysis, risk assessment. Show less
