Michelle Strobeck

Technical management of a new lab for clinical trials.

I am currently part of a team that manages a clinical genomics laboratory.

Established and verified a clinical COVID-19 testing environment in a 2-week time period. Managed and maintained QA/QC records and programs by writing all laboratory SOPs and ensuring CLIA compliances as well as establishing and assessing workflows, designs while implementing improvements. Supervised 3 shifts of ~12 lab technicians including hiring, onboarding, testing, process improvement, instrument validation, maintenance, performance management, corrective action, and training.

Collaborated in matrix with governance and SME stakeholders in lab design and writing, optimizing, validating of all SOPs. Functionally supervised all furniture and equipment installation with ~2 employees including hiring, onboarding, coaching, training, performance management and change management. Designed experiments to fulfill FDA EUA requirements for COVID-19 qPCR for ultra-deep metagenomic sequencing as well as ensuring safety and laboratory compliances including CAP / CLIA.