Nicholas Tomko
Bioanalytical Scientist Ii @Medpace
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WORK HISTORY
Bioanalytical Scientist Ii @Medpace
Cincinnati, OH, US
Develop and validate ligand binding assay (LBA) methods, such as ELISA, ECL, MSD, Real time-PCR, Flow Cytometry, for large molecule biologics and biomarkers• Draft study protocols/plans, bioanalytical methods, and study reports• Supervise all phases of bioanalytical assays to support non-clinical animal toxicology, clinical human pharmacokinetics, PD Biomarkers, and Immunogenicity studies• Communicate with internal and external resources for sample receiving, quality control, quality assurance, sponsor correspondence, etc.• Train and supervise technicians for performing method development, validation, and sample analysis• Fulfill responsibilities of Study Director/Principal Investigator, as prescribed in departmental SOPs and appropriate Good Laboratory Practice (GLP) regulations/standards• Perform CLIA certified, CAP accredited bioanalytical assays
EDUCATION
Eastern Kentucky University
BS
Case Western Reserve University
PhD
SKILLS
ABOUT NICHOLAS TOMKO
With over 6 years of experience in clinical and preclinical immunogenicity studies, I specialize in developing and validating bioanalytical assays to support regulatory submissions and therapeutic innovation. At Sarepta Therapeutics, I served as a Subject Matter Expert (SME) in immunology, contributing to internal and external studies through ligand binding assay design and immunoassay development. My work has enabled the successful execution of multidisciplinary studies and regulatory deliverables, demonstrating technical expertise and a commitment to advancing therapeutic pipelines. My career is defined by a focus on collaboration and precision in regulated environments, leveraging skills in technical writing and assay optimization to meet complex bioanalytical challenges. As a contributing scientist, I aim to drive impactful solutions in the biopharmaceutical industry, facilitating the development of innovative medicines that address critical patient needs.
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