Mike Mclean Email & Phone Number

Vancouver, British Columbia, Canada

Vancouver, British Columbia, Canada

South San Franciso

As a Process Development Engineer within the Translational Development R&D group, I worked at the interface of Automation, Clinical Operations and Quality Assurance. The overarching goal of this position was to maintain and improve the automated and manual biological sample processing in a state-of-the-art CLIA/CAP/ISO certified clinical NGS laboratory. Using a systems engineering methodology I was heavily involved in new product development and current product improvements in quality, efficiency and capacity. This required both a host of technical skills and key project coordination responsibilities. - Upgraded post-amplification bead cleanup and library consolidation protocols and executed an ANOVA Gage R&R verification experiment that showed < 2% CV and <3% error post-upgrade - Collaborated on new assay development to define and execute V&V, implementation, deployment and post-launch monitoring within the high-throughput automated NGS CLIA/CAP laboratory - RCA and resolution of tertiary-level robotic liquid-handler process failure during human plasma hitpicking which eliminated bubbles and dripping by100% - Wrote R Notebook data analysis and report-generating tools for service engineering which decreased TAT for scheduled preventative maintenance by 60%. - Delivered an instrument qualification IQ/OQ/PQ framework to define both the requirements and process for documentation, execution and stakeholder approval for new and updated laboratory instruments - Improved an on-deck gravimetric scale method for liquid class development fleet-wide which reduced timeout failure rate by 95% for service engineering - Defined and documented the RCA and CAPA for a first-of-its-kind failure mode for the Tecan EVO liquid handlers which caused total failure during hitpicking which convinced the OEM to provide ~$100K in repair parts

San Francisco

Working as a Laboratory Automation Technician at a startup like uBiome meant that I was working very hard to not only keep the robotic fleet for NGS sample processing running but to also delve deep into technical debt. In addition to repairing and IQ/OQ duties, I quickly became the SME on the intricacies of our specific Beckman Coulter robots liquid handling performance which led to my role in creating a central repository of protocols and robot configurations. This project to standardize the fleet led into to the creation of a design control process for our hardware engineers and the discovery of two major CAPAs.- Built, repaired, and performed IQ/OQ on Beckman Coulter robots in our clinical labs. - Pioneered an automated liquid handling guide to transition from manual to automated workflows- Performed a system-wide audit and standardization project of all automated clinical protocols which revealed 50% CV and 10-30% error in primer block creation- Discovered and resolved a PCR mastermix formulation CAPA that decreased library prep QC failure rate by 40% and increased liquid handling accuracy by up to 20%- Represented the automation team in a cross-functional product continuous improvement mission team where I proposed and completed project specs for clinical assay development and deployment workflows

Lion'S Gate Hospital, Vancouver, B.C.

Lion's Gate Hospital biomedical department is a young group that is responsible for 6 additional sites including this one. This requires weekly travel by car, ferry and sometimes plane where we work as a sole charge or duo to triage critical maintenance and unforeseen emergencies. Every day I have to juggle corrective work, minor equipment purchasing, education, IT issues, training, email correspondence and the upkeep and cleaning of the shop itself.My job focus as a senior tech is on operating room and intensive care units including: ventilators, dialysis machines, anesthesia patient monitors, defibrillators, electrosurgical devices and surgical lasers to name a few modalities.

Vancouver, Canada Area

An internship R&D project to design-build a new type of temperature and humidity sensor that resulted in a paid contract where I produced five iterations of the prototype device. The sensor was for a unique application of dynamically modelling the energy added to a unit of exhaled air by a ventilated patient. This approach would provide improved, objective feedback to the respiratory therapist setting the ventilator parametersEvery day of this project involved C-programming, Octave data analysis, interfacing Arduino and Teensy with lab analog signal processing equipment and fabrication of improved test jigs and electronics circuit design. Throughout there were weekly engineering reviews with the CTO and engineering staff as well as lengthy debrief with the Director of R&D at the conclusion of project documentation to determine future project viability.

Vancouver, Canada Area

Learned from a variety of mentors with over 200 years of biomed experience in the shop. Soft skills were emphasized such as communication with nursing staff, patient-staff etiquette and how to work in a large collaborative team on database of 1000s of medical assets and maintenance schedules. I was responsible for all infusion pumps from the Emergency department and Operating room and was invited to partake in OR video endoscopy/microscopy construction and upgrades. This required working with machinists and biomed techs to create custom parts under a strict schedule. At the completion I collaborated on the creation of training documents designed for future students that would outline learning outcomes and resources. The goal was to define the specific hard and soft skills and link the students with biomedical technologists we had identified as excellent mentors thorough an interview process

Victoria, British Columbia, Canada

When I was hired Spinnakers was looking to transition from a staid, old-school brewpub to a more agile and higher throughput venture. This required a microbiology lab to ensure that the increase in production could be monitored with some easy-to-perform assays. Additionally, it needed to be relatively cheap and occupy a small space.While working on this, I also learned the craft of brewing and conditioning beer. This led to identification of areas of potential microbiological growth and prompted a change in cleaning techniques. I was also asked to validate the decades old yeast pitching technique and monitor the health of various yeast populations as they were used in brewing. This required some biochemical and microscopic techniques which I created SOPs for with an eye for a non-scientist to perform accurately

Victoria, British Columbia, Canada

I worked as a stem cell researcher in the Choy lab with funding from a Summer Undergraduate Research Award and a MPS Summer studentship award. We worked toward the goal of reprogramming human fibroblasts to iPS stem cells carrying a germ-line lysosomal storage disease, Gaucher's. This was a new direction for the laboratory so I was focused on testing and validating different genetic engineering and mammalian cell culture methods to reprogram terminally differentiated human fibroblasts. To accomplish this I sourced a new microscope with capable of stereoscopic and phase contrast microscopy. Using this new hardware I developed a SOP to visualize, isolate and transfer monoclonal iPS colonies. This technique has been used in subsequent publications by the lab- Created p53 knockdown mi-RNA expressing constructs for better stem cell reprogramming in adult fibroblasts primary cell line.- Managed lab supplies, negotiated with reps, procured and installed a new video microscope system that allowed me to develop an iPS colony-picking protocol used by the lab in subsequent publications

Vancouver, British Columbia, Canada

I was honoured to work on a proteomics research project to detect adult granulosa-type ovarian cancer at an early stage. Defined by a single basepair mutation in FoxL2, this cancer sub-type was a selected for development of a GC-MS/MS Multiple reaction monitoring assay. Several ovarian cancer cell lines were transfected with normal, oncogenic and nonsense mutation versions of the gene for protein expression. Then antibody-affinity purification and western blot were used to validate the success and purity of the protein expression. After the initial run on GC-MS/MS several candidate peptides were selected for the quantitative MRM assay. In the process of this experiment it became obvious that there were previously undocumented post-translational modifications of this protein; Thus, I was able to propose further research, based on some MS/MS findings, to study the modifications of the oncogenic protein.- Developed 8 recombinant FOXL2 transcription factor mutant expressing mammalian cell lines to examine changes in PTMs- Created and tested a heavy peptide diagnostic LC-MS/ MS MRM assay specific for FoxL2 C134W adult granulosa tumours- Presented findings at two poster symposiums and provided scientific writing critiques to graduate and fellow co-op students

Biomedical Engineering Technology, Biomedical/Medical Engineering

Bachelor Of Science (B.S.), Microbiology And Immunology

Activities and Societies: Honours and Co-Op. Focused on proteomics, cancer and stem cell genetics.

Front End Development Certification, Computer Software Engineering