Michaela has been in the biotechnology industry for over 6 years, focused on In Vitro Diagnostics (IVD) manufacturing, quality control, quality systems and product development. Michaela joined NAMSA in November 2021. Prior to NAMSA, Michaela worked at DiaSorin, Inc., excelling in various advanced roles such as the Manufacturing Supervisor, where she managed several complex product development projects for new and redeveloped IVD assays. She successfully led the product development projects’ commercialization strategy from feasibility to post-launch. Michaela has a distinct passion for product quality and ensuring compliance and best practices, and always considers the patient impact and risk.
Michaela graduated from the University of Wisconsin – River Falls with her Bachelor’s degree in Biomedicine, where she was involved with the Undergraduate Research and Scholarly Creative Activities association, the Honors Society and received the Excellence in STEM award. She holds a number of different certificates and has taken many post-baccalaureate courses including Project Management from the University of Minnesota (Minneapolis, MN), Developmental Leadership from Dale Carnegie and Lean/RCA/Six Sigma classes.
CORE COMPETENCIES
- Proficient in project management for commercialization of diagnostic products, feasibility through post-launch and specialization in IVD manufacturing, quality control, quality systems and product development in Clinical Laboratory Improvement Amendments (CLIA)
- Technical Lead and Project Manager for high-profile LIAISON Vitamin D assay product lines, Hematology reagents and IVD kits
RECENT PROJECTS