San Francisco Bay Area
I am an engineer and manager with 20 years of experience in technology development for the life sciences, with a focus on systems engineering, program management and manufacturing transfer. I have led a variety of complex projects for both RUO and IVD products, involving the integration of hardware, software and reagent subsystems. I draw heavily on my experience as a co-founder of a biotech startup to build teams, infrastructure and processes that blend startup agility with big-company best practices.
Karius is developing novel diagnostics for infectious disease, based on metagenomic next-generation sequencing (NGS) technology. • Led product development effort responsible for creation of a novel in vitro diagnostic (IVD) • Gathered customer input through in-person site interviews; synthesized into customer requirements • Evaluated, engaged and managed external engineering contractors to support early concept work • Led build-out of new 6,000 sq-ft molecular diagnostics CLIA lab with capacity for 100k samples/year
Worked on new product development in the Genetic Analysis (CE/qPCR) division, including the SeqStudio Genetic Analyzer system • Created new facility for rapid R&D prototyping and pilot manufacturing of single-use cartridges • Led hiring for team; managed setup of laboratory and in-house production space • Developed concepts for novel microfluidic sample prep chips; inventor on Patent WO/2017/041023 • Operated under ISO 13485 design control process
Oversaw the development and implementation of operational and quality systems, across a new 7,000 sq-ft molecular diagnostics service laboratory. Systems operated in a highly regulated environment and were designed for CLIA/CAP-compliance.
Led the build-up of Boreal’s in-house manufacturing capabilities and systems, and managed all activities of the manufacturing team. Delivered over 100 high-complexity electrophoretic instruments, 10k consumable cartridges, and hundreds of custom reagent kits during production scale-up phase.
Designed, developed and tested complex electrophoretic instruments and consumable cartridges. Performed extensive rapid prototyping, using in-house tools such as waterjet cutter, laser cutter, CNC mill. Named as Inventor on US Patent US 2011/0048950A1 covering this work.
Designed, fabricated and validated a custom bulk molten agarose dispensing system, for highly automated preparation of slab electrophoresis gels. After I integrated the system into the Genome Centre's production group, it was used daily for several years, sharply reducing technician labour compared to the previous manual process.