AAAudrey Arvonen
@audreyarvonen
Research scientist specializing in assay development and quality analysis.
United StatesWhat I'm looking for
I am a dedicated Research Scientist III with extensive experience in assay development and quality analysis, currently working at Amnio Technology. My role involves leading the development of a collagen assay for a product undergoing clinical trials, ensuring compliance with FDA guidelines. I have successfully authored and validated methodologies that enhance assay reliability and reproducibility, and I take pride in training junior staff to maintain high standards in laboratory practices.
Throughout my career, I have collaborated closely with regulatory staff to facilitate IND and BLA submissions, providing robust datasets that substantiate product efficacy and safety. My contributions to scientific literature include co-authoring impactful papers on innovative treatments for diabetic foot ulcers and the biocompatibility of amniotic membranes. I am passionate about advancing research and development initiatives, having spearheaded the introduction of new laboratory equipment and developed comprehensive SOPs to ensure regulatory compliance.
Experience
Work history, roles, and key accomplishments
Research Scientist III & Quality Analyst
Amnio Technology
Jun 2023 - Present (2 years 1 month)
Led the development of a collagen assay for a product undergoing clinical trials, at the FDA's request. Authored and conducted its validation per ICH guidelines. Led the investigation and optimization of potency assays for an FDA clinical-trial product, establishing an ICH-compliant methodology that enhanced assay reliability and reproducibility.
Research and Development Technician
Amnio Technology
Jan 2021 - Present (4 years 6 months)
Conducted a variety of experimental assays, using manufacturer protocols and current published research, to drive insights in products undergoing clinical trials. Developed comprehensive Standard Operating Procedures for the new lab, enhancing R&D and Quality initiatives, which led to a streamlined workflow and improved compliance with industry standards.
Specimen Processor Technician
Sonora Quest Laboratories
Jan 2018 - Present (7 years 6 months)
Processed blood and urine specimens while adhering to safety protocols, ensuring accurate and reliable results for patient care. Managed laboratory information system (LIS) with precision, exceeding departmental accuracy standards.
Education
Degrees, certifications, and relevant coursework
AUArizona State University
Bachelor of Science, Biological Sciences (Genetics, Cell, and Developmental Biology)
Completed a Bachelor of Science in Biological Sciences with a focus on Genetics, Cell, and Developmental Biology. Gained comprehensive knowledge in various biological disciplines, preparing for research and scientific roles.
Availability
Location
United StatesAuthorized to work in
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