• Leads and manages the Quality review process for new human therapeutic product and major (Level I) post-approval change submissions. • Works collaboratively and in parallel with Clinical and Non-Clinical evaluation groups to come to a final Health Canada Marketing Authorization decision.• Provides regulatory advice to senior management on risk/benefit assessment and/or risk management strategy within the framework of the Canadian or ICH Guidance for new active substances and post-approval change requests.

• Managed daily operations at an institutional research laboratory (Health Canada Center for Vaccines Evaluation; Protein Chemistry Section).• Responsible for multiple recombinant protein manufacturing, methods development, and sample analysis projects involving human therapeutic products.• Experienced leading development, production, and testing of biologics using a wide range of techniques including, but not limited to: Protein conjugation and cross-linking, SPR analysis, FRET and CD spectrophotometry, and calorimetric methods. • Responsible for monitoring the implementation and adherence to a quality control program for test and sample materials.• Directed and providing leadership to a unit of two junior chemists (CH-02 level) and up to three scientific support technicians (EG-04 and EG-05).