New Westminster, British Columbia, Canada
Experienced Principal with 20+ years experience in the pharmaceutical industry, specifically in cGMP API manufacturing, CMC technical operations, and CMC Regulatory. Authored technical reports (e.g. process research & development, process impurities, risk assessment of genotoxic and nitrosamine impurities, ICH stability and storage conditions, GMP site assessments), and authored CTD Modules 2 & 3 sections for USNDA, Canadian NDS, EU MAA, EU post-approval variations (e.g. changes in API supplier, retest and shelf-life period extensions, specifications, raw material specifications). Working knowledge of regulatory requirements/guidances applicable to human drugs (ICH, FDA, EMA). Worked remotely within a global team comprised of CMC Manufacturing, Regulatory Affairs, Quality Assurance, Supply Chain & Logistics, contract management, and intellectual property.
Consulting services and project management in API process development and manufacturing, CMC technical services and CMC regulatory support of pharmaceutical drug development. My 20+ years experience in the pharmaceutical industry spans medicinal chemistry, API process development, and more recently 8 years overseeing CMOs in process transfers and development, process validation, technical support for QA cGMP site audits, authoring/reviewing marketing authorization dossier CTD drug substance sections (e.g. NDS, NDA, MAA), post-approval variations, and responses to regulatory questions.
Project management of third party commercial cGMP manufacturing sites and technical support for activities such as process transfers, process validation, deviation investigation, trouble-shooting and technical aspects of API route changes, improvements or other process changes for commercial products. Participant on Quality Assurance (QA) site audit team for third party API manufacturing sites. Worked closely with QA for review/approval of master and executed batch records for API, deviation investigations, and change controls. Chemistry, Manufacturing & Controls (CMC) technical support for regulatory submissions (e.g. US NDA, EU MAA), including authoring/review of CTD drug substance sections, preparation of responses to regulatory queries/requests, and risk assessments (e.g. genotoxic, elemental, or nitrosamine impurities).
Project management of third party commercial cGMP manufacturing sites. Responsible for trouble-shooting and technical aspects of API route changes, improvements or other process changes for commercial products, and for providing technical support for activities at third party commercial manufacturing sites. Participated in Quality Assurance site audits at third party manufacturing sites. Work closely with Regulatory Affairs by authoring/reviewing CMC regulatory documentation for worldwide submissions and for updates/changes to approved marketing authorization dossiers.
Management of medicinal chemistry, synthetic chemistry and bioanalytical chemistry departmental activities, and project/departmental budgets Project team leader for preclinical development of an oral anti arrhythmic agent, including medicinal chemistry, process chemistry, ADME and PK and in vivo pharmacological studies Team leader for Process Research group charged with route identification and assessment for efficiency and cost-of-goods reduction for a potential manufacturing route. Process was successfully scaled by CMO to metric ton. Management of internal and external studies entailing process feasibility/optimization/scaling; synthesis of reference materials for process impurities and metabolites; radio label synthesis Participated in preparation of CMC sections for IND, Drug Substance sections (Characterizaion, Impurities and Reference Standards for Drug Master File and NDA. Performed QC and QA reviews of technical and regulatory documentation, including Investigator's Brochure (preclinical and clinical sections). Chair of Cardiome Animal Care Committee (2007 - 2012)
Directed team comprised of medicinal/synthetic and bio-analytical chemists in drug discovery activities, including gram-scale synthesis of novel anti arrhythmic agents metabolic and pharmacokinetic studies and measurement of tissue drug levels Assessment and selection of contractors for GMP manufacture of drug substance; management and technical/scientific guidance of Cardiome studies conducted by contractors Coordination of activities supporting IND/NDA, e.g. parenteral formulation assessment; analytical method validation; establishment of GMP release specifications; preclinical ADME; radio label synthesis; GMP drug substance manufacture; identification and characterization of drug substance isomers, process impurities, metabolites; toxicological qualification of process impurities Preparation of CMC section of Clinical Trial Application (CTA) and Investigational New Drug Application (NDA) for Phase I and II studies of vernakalant injection; participation in preparation of Drug Master File/New Drug Application (NDA) for vernakalant injection
Hapten design for generation of proteolytic abzymes