Michael Kjome Email & Phone Number

Saint Paul, MN, US

• Develop project goals for direct reports that meet business objectives
• Accountable to ensure project achievements are met, remove roadblocks to enable teams to meet project milestones
• Staff projects to ensure success while building talent within group
• Employ the Danaher Business System continuous improvement tools to enhance current development processes
• Collaborate within department and cross functionally to achieve business priorities
• Mentor direct reports in their growth and development plans; set impactful development objectives; provide stretch assignments to develop talent

• Provide staff supervision of daily activities
• Sustain lab productivity and compliance to meet department and corporate objectives
• Staff projects to ensure success while building talent within group
• Seek opportunities to improve efficiency and increase capacity for the business
• Communicate project status, escalates issues to high level management, users and staff
• Provide staff development opportunities based on associate and business needs

• Facilitated cross-functional interactions and decisions based on assay performance, customer needs and business priority
• Author and review documents including development reports, SOPs, assay transfer protocols/reports

• Design and deliver experimental results that progress the company’s project forward
• Lead analysis standard work initiatives based off of FDA updated CLSI guidelines
• Launch Design Change Orders to bring current product(s) in alignment with FDA clinical and laboratory standards

• Execute immunoassays studies on new platform to characterization performance
• Investigated results not meeting specifications on new platform
• Present and discuss experimental results at group and project team meetings
• Cultivate and apply in-depth knowledge of current immunoassay products and customer needs

• Executed studies in the optimization of a high-density molecular microarray for genomic identification of seasonal and non-seasonal strains of influenza virus
• Reduced an 8-plex nested RT-PCR assay from 12.5 hours down to 4 hour without affecting sensitivity or specificity
• Use understanding of virology and molecular biology to advance neural network development in identifying novel strains of influenza viral genome

• Worked with a team to implement quality systems to obtain ISO 13485 Quality Management System certification
• Wrote technical reports and executed analytical studies that resulted in CE mark for a quantitative detection of individual virus particles
• Execute verification, validation studies and documentation of new in vitro diagnostic assays in compliance with FDA 510(k) clearance submission

• Performed feasibility experiments to develop a sample-to-answer molecular in vitro diagnostic test to detect multiple viral respiratory infections from human nasopharyngeal swab specimen
• Collaborated with software and system engineers to develop a disposable consumable cartridge and fully automated system capable of performing the assay
• Integrated a molecular and a protein low-density microarray together for simultaneous processing
• Used molecular biology techniques to develop in-process quality control on real time qRT-DNA assay