As the Director of Assay Development, I managed a team of 11 people responsible for the development, verification and validation of PCR based point-of-care tests for environmental, genotyping and infectious disease assays on the portable Genomadix CUBE system. I coordinated multiple concurrent assay development projects ensuring appropriate resource distribution and that deliverables were met. All projects were conducted under the quality system guidelines of ISO 13485 with submissions made to Health Canada in addition to supporting responses to the FDA during 510(k) review.

Led the assay feasibility Product Development team that was responsible for assay prototype design, optimization and production, including: primer design and screening, PCR optimization, control selections, sample processing and extraction as well as production of prototype devices. Institutional Biosafety Officer and PHAC pathogen and toxin license holder.

Managed the assay feasibility Product Development that was team responsible for assay prototype design, optimization and production, including: primer design and screening, PCR optimization, control selections, sample processing and extraction as well as production of prototype devices. Institutional Biosafety Officer and PHAC pathogen and toxin license holder.

Lead assay developer responsible for the design, optimization and early verification of molecular diagnostic assays. Utilized nucleic acid amplification techniques including PCR, multiplex PCR, qPCR and Sanger sequencing to develop effective diagnostics. Developed sample pre-processing techniques and utilized various nucleic acid purification methods for a wide variety sample types, Employed basic microbiology (growth and counting) to support development.

Assay developer responsible for the design, optimization and early verification of molecular diagnostic assays. Utilized nucleic acid amplification techniques including PCR, multiplex PCR, qPCR and Sanger sequencing to develop effective diagnostics. Developed sample pre-processing techniques and utilized various nucleic acid purification methods for a wide variety sample types, Employed basic microbiology (growth and counting) to support development.

Bridged the gap between Research and Manufacturing departments by creating manufacturing documentation such as Device Master Records (DMRs) and Batch Production Forms (BPFs). Performed ‘alpha’ verification studies to set parameters for formal verification and validation as well as robustness and guard-band style studies.

Bridged the gap between Research and Manufacturing departments by creating manufacturing documentation such as Device Master Records (DMRs) and Batch Production Forms (BPFs). Performed ‘alpha’ verification studies to set parameters for formal verification and validation as well as robustness and guard-band style studies.