Research and Evaluation Office

Laboratories and Genetics Branch

Capacity Planning and Analytics Division

Health Analytics Branch

Analytical Operations► Established project plans with pharmaceutical clients to quality test their drug products and materials.► Oversaw method development, stability and release testing for materials spanning pre-clinical to commercial product. ► Client's point-of-contact for technical updates, material transfer, scheduling and FTEs/POs.

Analytical Operations ► Authored GMP protocols, methods, and reports to validate drug products and materials.► Common testing included assay and impurities by HPLC/GC, residual solvents by GC, heavy metals by ICP-MS, particle size by laser light diffraction, and water content by KF titration.► Established testing parameters and criteria that best suited the product's intended use and met the applicable Reg requirements (USP, EP, JP, ICH).► Developed a strong understanding of… Show more Analytical Operations ► Authored GMP protocols, methods, and reports to validate drug products and materials.► Common testing included assay and impurities by HPLC/GC, residual solvents by GC, heavy metals by ICP-MS, particle size by laser light diffraction, and water content by KF titration.► Established testing parameters and criteria that best suited the product's intended use and met the applicable Reg requirements (USP, EP, JP, ICH).► Developed a strong understanding of industry best practices for testing drug products, raw materials and in-process samples for research, stability and market release. Show less

Canadian Clinical Development► Served as the country study manager for Phase II & III clinical trials investigating HIV drug Dolutegravir. ► Served as associate contract manager responsible for drafting clinical study budgets (per site) and negotiating contract agreements with physicians.► Managed the study start-up of the 2014 Relenza trial, providing protocol training to all participating physicians, nurses and pharmacists across Canada.

Enzyme Characterization and Kinetics R&D► Led bench-scale research projects to characterize novel enzyme variants. Successful variants were incorporated into a biofuel production process. ► Wrote and executed work plans for enzyme purification and analysis. ► Modelled assay data using Excel Solver. ► Troubleshot and optimized kinetic assays to suit new experimental conditions.► Drafted reports to support patent applications for novel enzyme variants.

Enzyme Characterization and Kinetics R&D► Expressed protein variants from bacteria, yeast and fungi for bench-scale analysis.► Purified target protein from crude filtrate using various chromatography techniques (affinity, ion-exchange, SEC/GPC, IMAC, hydrophobic-interaction).► Routine protein characterization (ELISA, Western Blot, SDS-PAGE) and quantification (Bradford, BCA and UV) on purification intermediates and products.► Prepared chromatography resins/columns and… Show more Enzyme Characterization and Kinetics R&D► Expressed protein variants from bacteria, yeast and fungi for bench-scale analysis.► Purified target protein from crude filtrate using various chromatography techniques (affinity, ion-exchange, SEC/GPC, IMAC, hydrophobic-interaction).► Routine protein characterization (ELISA, Western Blot, SDS-PAGE) and quantification (Bradford, BCA and UV) on purification intermediates and products.► Prepared chromatography resins/columns and maintained the AKTA purification systems (Prime, Prime+, FPLC, Xpress). Show less