As Associate Director of Bioprocess Engineering, I am responsible for final scale-up and transition to GMP readiness of all Triumvira’s manufacturing processes inclusive of initial evaluations of automated and large-scale equipment, proof of concept end-to-end in house manufacturing runs, technical transfer of processes to internal and CDMO-based manufacturing teams, batch record generation and authorship of CMC sections of FDA and Health Canada regulatory filings that pertain to the manufacturing process, associated product characterization and process development activities. This role reports to the Executive Director of Technical Operations and works closely with both Analytical Development and Quality teams. Key Accomplishments: • Fully closed and automated Triumvira’s autologous manufacturing process by integrating automation up- and down-stream of the Cocoon Bioreactor.• Led the development of Triumvira’s allogeneic leukapheresis processing procedure.• Generated electronic batch records for the allogeneic leukapheresis and full autologous manufacturing processes.• Oversaw the technical transfer, pilot runs, and engineering runs of the allogeneic leukapheresis and full autologous manufacturing runs at Triumvira’s GMP manufacturing facility.• Designed and executed studies to optimize the Cocoon Bioreactor protocol to maximize drug product yield from a single manufacturing run.• Wrote manufacturing and process development CMC sections of Triumvira’s TAC01-HER2 IND and CTA amendment as well as Triumvira’s TAC01-CLDN18.2 IND and CTA initial submission.• Oversaw the development and implementation of a technical training program on process specific equipment and procedures for new GMP manufacturing staff.• Led the whole blood and leukapheresis processing efforts required to identify top donors for Triumvira’s allogeneic program.

As Process Development Lab Manager, I reported to the Director of Process Development and was responsible for the continuous improvement of Triumvira’s autologous manufacturing process and support of ongoing clinical activities while simultaneously providing on-site leadership during the growth of Triumvira’s Hamilton-based development facility from 6 to 35 employees. Key Accomplishments: • Led the development process to transition from manual, culture-bag manufacturing to automated manufacturing in the Cocoon Bioreactor.• Oversaw the technical transfer of the Cocoon manufacturing process to Triumvira’s CDMO including pilot and engineering runs.• Designed manufacturing process flow diagrams and contributed to manufacturing process and process development sections of Triumvira’s TAC01-HER2 IND and CTA submissions.• Aided in the selection, purchase, and installation of equipment to outfit Triumvira’s Hamilton-based development facility.• Designed a basic laboratory training program covering lab safety procedures and the use of standard tissue culture equipment and laboratory software. Provided training to over 20 new hires. • Implemented a Process Facilitator position to carry out routine facility tasks such as performing equipment maintenance, running OQ and PQ programs on critical instruments, checking safety equipment function and managing receipt of incoming materials.

The Researcher position was the second full-time position at Triumvira and was responsible for the development of Triumvira’s first GMP manufacturing process and subsequent technical transfer to a CDMO partner.Key Accomplishments: • Completed the development of Triumvira’s initial TAC T cell manufacturing process and oversaw the technical transfer of the manufacturing process into Triumvira’s CMDO• Oversaw pilot and engineering runs for Triumvira’s TAC01-CD19 program at the CDMO.• Performed purity, residual and stability testing of TAC01-CD19 drug product generated in engineering runs as required for FDA IND and Health Canada CTA submissions.• Wrote a comprehensive report, referenced in the TAC01-CD19 regulatory filings, describing the process development activities undertaken to transition from the academic manufacturing process utilized at McMaster University to the large-scale, GMP manufacturing process utilized at Triumvira’s CDMO.

Developed Triumvira Immunologic Inc.’s initial small-scale, GMP-ready TAC T cell manufacturing process from the academic process utilized at Dr. Johnathan Bramson’s lab. Evaluated and transitioned to using all GMP reagents. Initiated technical transfer activities to a CDMO facility. Wrote SOPs and work instructions to support the manufacturing process and associated characterization assays. Performed in-house manufacturing for in vitro and in vivo studies required for final TAC lentiviral vector selection (TAC01-CD19 program). Contributed to the initial paper describing the TAC molecule (Helsen et. al., Nature Communications) by performing in vitro assays and proof reading.

This research group investigates the molecular mechanisms contributing to embryonic development. My contributions included the development of a custom microscope incubator, the development of MATLAB scripts to automatically analyze microscope images and the investigation of cell-cell junctions in embryonic wound healing. Individually I took the incubator for conception to implementation gaining experience in consulting, CAD, electrical design and V&V testing.

Characterized various manufacturing failure modes in Daktari’s in house manufacturing of point-of-care microfluidic cartridges. Developed a SharePoint-based relational database tracking individual cartridges through manufacturing including failure reporting tools at each manufacturing unit operation. Reported failure mode frequencies and the cost associated with manufacturing failures at various points during manufacturing at bi-weekly manufacturing team meetings. Wrote Python scripts interfacing with lab equipment utilized in quality testing and in custom manufacturing tooling. Performed instrument release and cartridge lot release testing using healthy donor whole blood samples.

• Helped maintain the lab’s Drosophila stock collection• Prepared movies from time lapsed, confocal microscopy photos for analysis • Performed image analysis to investigate the differences in cell density between embryos in late and early stages of development