Hedieh Attai

Senior Scientist @Illumina

San Diego, CA, US

Study lead for design verification and validation (V&V) and feasibility testing for product development process (PDP) requirements• Supporting in vitro diagnostic (IVD) assay development for oncology companion diagnostic (CDx) claims, testing genetic variation in patient samples, including peripheral blood and bone marrow aspirate• Supervising a team of scientists, designing and organizing studies required to meet regulatory standards for FDA approval of product submissions• Authoring documentation for regulatory submissions to the FDA• Effectively communicating study results in team presentations, collaborating with cross-functional groups • Analyzing large data sets and evaluating against acceptance criteria• Executing study experiments, preparing samples, library preparation, and sequencing on NextSeq 550, NovaSeq and NovaSeq X instruments• Experience in whole genome sequencing (WGS), targeted panel sequencing, and automation

University of Missouri-Columbia

Doctor of Philosophy (Ph.D.), Biological Sciences

University of California, Berkeley

Bachelor's degree, Molecular and Cell Biology: Immunology

College of the Canyons

Associates Degree, Biological Science