Eden K. Michael

Experience

• 

  Warsay Yikealo Scecondary School

  Sept 2010 - Sept 2012

  Math Teacher

  • Designed lesson plans for intensive mathematics, advanced algebra and geometry including functions, statistics and trigonometry. Utilized discussion based lessons in order to promote deeper understanding of the concepts• Prepared more than 800 question papers for formative and summative assessments to develop students’ aptitude, logic and intellectual skills and checked more than 10,000 answer sheets per year.

• 

  Florida Institute of Technology

  Oct 2013 - Jun 2015

  Vascular Tissue Engineering• Planned, organized and executed experiments for tissue engineering small diameter vessels including literature review and experimental design and scaffold preparation• Led experiments including biomaterial synthesis, material characterization using SEM and confocal imaging, mammalian cell culture and maintaining. Developed and performed different assay including live/dead, DNA and qrtPCR to evaluate viability and phenotype of cells • Purchased materials such as disposables, chemicals and biological supplies.• Collected and analyzed results of scaffolds using SEM and confocal imaging, and cells on scaffolds using IF imaging, qRT-PCR techniques.• Presented scientific results and documented findings in technical report for primary investigator and laboratory peers.• Fabricated functional scaffolds that incorporated carbon monoxide releasing molecules. Seeded rat smooth muscle cells on the scaffolds and performed appropriate assays to determine the effect. Show less

  • Research Assistant

    Aug 2013 - Jun 2015

  • Graduate Teaching Assistant

    Sept 2013 - May 2015

  • Research Assistant

    Oct 2013 - Dec 2013
• 

  Roche

  Jan 2016 - Dec 2021

  • Spearheaded the design and development of point-of-care molecular PCR assays, contributing to multiple product milestones within FDA-regulated design control frameworks.• Conducted and analyzed 50+ complex laboratory experiments to support feasibility and verification phases, producing high-impact technical reports and data presentations.• Collaborated with cross-functional teams to troubleshoot technical challenges, resulting in resolution of assay performance issues and improved product stability.• Influenced strategic decision-making by delivering data-driven insights from clinical performance studies and root cause investigations.• Co-led project planning sessions, helping align scientific goals with business timelines and compliance requirements.• Engineered novel assay methodologies, resulting in a 30% enhancement in sensitivity and specificity, validated across 100+ clinical samples to comply with regulatory standards. Show less

  • Scientist II Assay Development

    Sept 2020 - Dec 2021

  • Scientist I Assay Development

    Jan 2017 - Aug 2020

  • Scientist

    Jan 2016 - Jan 2017
• 

  Cepheid

  Jan 2022 - now

  Sr. Scientist NPI

  • Successfully transferred multiple IVD assays from R&D to manufacturing and led the launch of three IVD products, resulting in streamlined production and improved time-to-market.• Authored and implemented 10+ critical manufacturing documents (BOMs, SOPs, Work Instructions, test worksheets) and led validation efforts (test method validation, risk mitigation), ensuring compliance and readiness for FDA and international submissions.• Partnered with Supply Chain and Procurement teams to secure long-lead components and supported on-time prototype builds, while also delivering training and guidance to streamline knowledge transfer in manufacturing.• Contributed to the setup and rollout of promotional product catalogs in collaboration with cross-functional teams, supporting marketing strategy and launch readiness.• Directed cross-departmental initiatives that facilitated the seamless adoption of innovative diagnostic technologies, reducing time-to-market by 30% through strategic planning and execution of pilot projects. Show less