Clinical Research Quality Control

Anahita (Ana) Kiavand

Sunnyvale, CA ***** 206-***-**** ********@*****.*** www.linkedin.com/in/anahita-kiavand SUMMARY

Molecular biologist/Microbiologist with expertise in assay development, in vitro infectious disease diagnostics, point-of- care, medical devices, microfluidics, and clinical research. Highly developed communication and interpersonal skills, efficient, reliable, organized, adaptable, resourceful, self-motivated, responsive and detail oriented. Master’s degree in Biotechnology/Bioinformatics from the Johns Hopkins University with recorded publications in the field. Active participant in cross functional teams including quality control, production, engineering and senior leadership. More than 15 years of experience in both academics and private industry with a passion for ongoing learning and contributing to an organization’s growth and success. PROFESSIONAL SKILLS

Assay and process development Data analysis, presentation Effective Communication and business development Writing SOPs, reports Electronic lab notebook management Training, mentoring and troubleshooting Multitasking, Prioritization Adapting to constant changes Addressing technical and supportive needs Regulatory compliance GCP, ICH Clinical research

EXPERIENCE

Cepheid (Biotechnology research), A Danaher company. Sunnyvale, CA Developmental Science, government programs, the department of defense (DOD). Staff Scientist March 2022- February 2024

• Carried out, analyzed and documented experiments on GeneXpertâDx and âEdge systems, assisted with risk assessments, and managed associates contributing to the efficient utilization of government resources as well as commercial success

• Engaged in the "Innovation Challenge 2023" with a focus on sustainability, advocating for efficient communication practices to streamline processes and conserve time, energy, and resources in R&D Senior Scientist December 2020 – March 2022

• Exceeded expectations for directing Droplet Digital PCR assays to establish a unified unit of measurement for tropical fever large target panels, earning recognition with the prestigious 'Make It Happen Award'

• Led and executed the development of the “Xpert-Tropical Fever“ assay panel during the technical feasibility phase, in regulated GLP and GMP working environment

• Worked Proficiently on GeneXpertâ Dx and ® Omniâ systems, ensuring compatibility and efficiency, and conducted comparator studies with BioFireâ FilmArray to validate assay performance

• Resourced efficient tools, impacting ergonomic aspects of work environment for associates, daily management University of Washington, Department of Genome Sciences, Seattle WA Research Scientist Engineer December 2018 – October 2020 Establishment, development and advancement of a new pipeline for “Seattle Flu Study” at Brotman Baty Institute (BBI) and the Northwest Genomics Center (NWGC) in collaboration with Fred Hutch and Seattle Children’s along with technologies from ThermoFisher Scientifics and Illumina, Inc.

• Tracked thousands of specimens to rapidly detect and sequence viral genomes

• Executed “SARS-CoV-2” validation assays for transitioning to CLIA lab

• Communicated and coordinated efforts to launch SCAN (Seattle Coronavirus Assessment Network) for public health leaders in king county to track the spread of Coronavirus

• Moved pipeline components to automated liquid handlers and robotics such as MANTIS, JANUS and high throughput gene expression TaqMan “OpenArray” technology

• Set up NGS library, Nextera XT; Sample quality control by Agilent Bioanalyzer and TapeStation Micronics, Inc. Acquired by Sony Corporation of America, Redmond WA Development Scientist August 2007-August 2018

Development and Advancement for the near patient point of care molecular tests for infectious disease diagnosis. A unique technology platform called PanNAT® - FDA-cleared for medical diagnostic system, E.coli test.

• Sourced, researched and developed challenging endogenous mRNA controls, which were utilized company-wide

• Developed a unique, stable formulation for the desiccation of a “RNA assay buffer” to be used in PanNAT®

• Designed Primer and molecular beacon probe, utilizing Geneious software

• Developed of a unique melt-based approach to STR genotyping for forensic application, MRI collaboration

• Performed assay development for accurate detection of blood-borne pathogens- (HIV, HBV, and HCV), as well as respiratory projects. Effort included cell culture, extraction, qPCR and RT-qPCR using integrated Microfluidics- based system, Rotor-Gene6000 and BioRad-CFX instruments

• Conducted research and assay development for the Carbapenem-Resistant genes, demonstrating compatibilities

• Implemented an efficient workflow and ordering system ADDITIONAL RELEVANT EXPERIENCE

University of Washington, Department of Medicine, Seattle WA, Research Scientist Engineer Regional Center of Excellence for Biodefense and Emerging Infectious Diseases.

• Analyzed LPS purification and Lipid A biochemistry using different developed protocols, GC (Gas Chromatography) and MALDI-TOF (Matrix- assisted laser desorption /ionization time of flight) mass spectrometry and LC-MS

• Developed a sensitive analytical Liquid Chromatography-Mass Spectrometric-based assay for quantitation of amino containing moieties present in Lipid A

Taconic Anmed/Taconic-Farms, Inc, Rockville, MD, Senior Specialist Molecular Biology Supplier of laboratory animals, genetically engineered rodent models.

• Processed rodent samples for PCR infectious disease testing, serving as the main contact for molecular labs

• Troubleshot and reported results in LIMS; specialized in genotyping transgenic mice using real-time PCR

• Trained junior staff, appointed Head of Site Safety Committee, and maintained GLP records. The Naval Medical Research Center/ Walter-Reed Army, Silver Spring, MD, Research Assistant Henry M Jackson Foundation, advancing of military medicine by studies on virulent strains of C.jejuni, a major bacterial diarrhea disease-causing pathogen.

• Characterized Cjp29 protein in C.jejuni, a human pathogen

• Conducted cloning, electroporation, large-scale plasmid isolation and Sanger Sequencing

• Executed SDS-PAGE, Western blots, and expressed/purified recombinant proteins for polyclonal sera OTHER ACHIEVEMENTS

• Danaher PSP (Problem Solving Process) certificate in 2021, Cepheid “Make It Happen Awards” (2021,2022)

• Being volunteer for Department of Biology contributing to conservation biology and wildlife forensics; determining the origin of ivory in elephants (GeneMarker software) and SSC BioExpo Mentorship

• CITI program courses “Human Subjects Learners” and “Good Clinical Practice and ICH”

• “Supervisory Basics” and “Project management” certificate in POD program

• Part time Microbiology instructor at Bellevue Community College while working full time in the Fall of 2007, Taught 6 credit course- both lecture and related lab -Biology 250 (Microbiology)

• Extensive research on the effect of estradiol hormone on the fertility of rats, maintained three experimental groups of rats -Optional thesis project

• Member of Board of Directors and chair of a committee for condominium association of 770 units

• Self-development courses include, but are not limited to Python, R programming, Minitab, Tableau, Salesforce essential, Lean six sigma and product management certificate

• Support to the management of the main biochemistry laboratory in analyzing patients’ blood serum and urine as clinical laboratory technician

• Sale associate, surpassing sales expectation

EDUCATION

• Specialization in Professional Interdisciplinary Studies: Drug discovery, NGS and clinical trial management, UCSC

• Master of Science (MS) in Biotechnology /Bioinformatics, The Johns Hopkins University

• Bachelor of Science (BS) in Biology, Shahid Beheshti University PUBLICATIONS

https://scholar.google.com/scholar?hl=en&as_sdt=0,5&q=Anahita+Kiavand&oq=Ana, Also available in LinkedIn.

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