Experience

Yourgene Health Canada

• Canada
• Biotechnology Research
• 1 - 100 Employee

• Regulatory Affairs Manager, Quality Management System Manager

  • Jul 2021 - Present

  Project Management • Development and maintenance of ISO 9001:2015 certification • NetSuite implementation, administration • Regulatory certification of clinical laboratory instruments (C/US UL, CE) SOP development for production for IVDR (in vitro diagnostics regulations) • Hardware assembly, molecular biology reagents Project Management • Development and maintenance of ISO 9001:2015 certification • NetSuite implementation, administration • Regulatory certification of clinical laboratory instruments (C/US UL, CE) SOP development for production for IVDR (in vitro diagnostics regulations) • Hardware assembly, molecular biology reagents



Segra International Corp.

• British Columbia

• Quality Assurance, Senior Scientist

  • Mar 2015 - Dec 2020

  Responsible for initiating and managing the company’s licencing processes • Navigated a multi-year regulatory process; primary point of contact with regulators • Successfully attained and maintained multiple Health Canada, CFIA licences o Quality Management Systems authoring; workflow optimization o Guided development of a unique track and trace database o Database designs; data synthesis, management, reporting (external, internal) o Training and supervision of technicians, associates, managers Recent experience in Project Management • Project Management – new facilities design, buildouts, and commissioning; day-to-day operations o Facility designs to GPP and Health Canada security requirements; internal biosecurity o Budgeting; financial and throughput forecasting o Supervision of contractors; continual workflow improvement; monitoring and maintenance o Liaison between cross-functional teams; Gantt chart; documentation o Designed and refined client-facing regulatory- and business- related reports and forms o Shipping logistics of controlled substances (domestic, foreign) • Quality Assurance o QA contact for clients and external stakeholders o RCA, CAPA; continual improvement; document control o Statistics-based product and inventory sampling; trends analysis o Vendor and supplier qualification; calibration and maintenance; environmental monitoring o Consultation on experimental design • R&D – commercialization of molecular pathogen identification and detection assays o qPCR- and sequencing- based; allelic discrimination; melt-curve analysis o Validation and verification; synthetic and natural targets; sample extraction o Classical microbiology; environmental sampling Show less



Applied Biological Materials

• Canada
• Biotechnology Research
• 1 - 100 Employee

• Post Doctoral Scientist

  • Feb 2013 - Feb 2015

  • Developed a high-quality gene synthesis platform to create a new revenue stream o Implemented using low cost in-house developed reagents o SOP authoring, training • Developed rapid multiplexed detection and typing clinical assays for human pathogenic microbes, viruses o Conception, pre-clinical, clinical testing o qPCR; allelic discrimination; synthetic nucleic acids o Developed effective low-cost sample extraction o Validation, verification, stability testing o Documentation – technical, manufacturing, clinical, lay Show less



UBC Brain Research Centre

• Graduate Student (Ph.D.)

  • 2006 - Sep 2012

  • High throughput screening – automated liquid handling workstations, expression library cell-surface affinity screening; soluble protein engineering and bench scale production • Primary mammalian cell and tissue culture; gene replacement; BSL2+ Lentivirus • Transgenic rodent husbandry; CNS dissection • Imaging; quantitative image analysis; statistics • Molecular biology; peer training • High throughput screening – automated liquid handling workstations, expression library cell-surface affinity screening; soluble protein engineering and bench scale production • Primary mammalian cell and tissue culture; gene replacement; BSL2+ Lentivirus • Transgenic rodent husbandry; CNS dissection • Imaging; quantitative image analysis; statistics • Molecular biology; peer training



UBC Child & Family Research Institute

• Vancouver, BC

• Graduate Student (M.Sc.)

  • Sep 2002 - Jan 2006

  • Clinical sample accessioning; record keeping • IRB, consent/ assent authoring; clinical trial recruitment • Primary human cell culture; phlebotomy • Rodent blood sampling; necropsy • Cell sorting; multicolour FACS; cell stimulation; serological assay • Molecular biology; radionuclides • Clinical sample accessioning; record keeping • IRB, consent/ assent authoring; clinical trial recruitment • Primary human cell culture; phlebotomy • Rodent blood sampling; necropsy • Cell sorting; multicolour FACS; cell stimulation; serological assay • Molecular biology; radionuclides



BioTeach

• Vancouver, BC

• Lecturer

  • Sep 2003 - May 2004

  • History of molecular biology; fundamentals of molecular biology • Leading hands-on laboratory instruction • History of molecular biology; fundamentals of molecular biology • Leading hands-on laboratory instruction



Cubist Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Research Associate

  • Aug 2000 - Dec 2002

  Construction of high quality high titre BAC and cosmid libraries from cultured Streptomyces and from viable but non-cultivable soil microorganisms. I was also part of the in-house DNA sequencing team. Construction of high quality high titre BAC and cosmid libraries from cultured Streptomyces and from viable but non-cultivable soil microorganisms. I was also part of the in-house DNA sequencing team.



Terragen Discoveries

• Research Associate

  • Aug 2000 - Jan 2002

  Construction of high quality high titre BAC and cosmid libraries from cultured Streptomyces and from viable but non-cultivable soil microorganisms. Construction of high quality high titre BAC and cosmid libraries from cultured Streptomyces and from viable but non-cultivable soil microorganisms.