Recently the National Institute of Health has funded a center at the University of Missouri focused on evaluating gene therapy methods and outcomes in swine animal models. The Senior Research Associate is a member of the Somatic Cell Gene Therapy "Testing" group that evaluates animals' physiological and immunological responses to gene therapy reagents as well as to the altered genes themselves. This person's roles will include, but are not limited to, toxicology screens, PCR-based screens, the development, qualification/validation, and implementation of immunoassays/cell-based assays for determination of inflammatory responses in the test animals, and measurement of biomarkers in a GLP/GCP environment. The candidate will utilize multiple technology platforms, including thermocyclers, ELISA, fluorescence/luminescent plate readers, and flow cytometry. This position will also manage tissue/sample collections for the transfer, development, validation and execution of assays performed elsewhere.
Oversee development, validation and execution of immunoassays/cell-based assays for quantification of responses to gene therapy methods, assessment of immunogenicity, and measurement of releveant biomakers in biological matrices including tissue, serum and/or plasma.
Oversee the validation and execution of molecular methods (e.g. PCR and quantitative PCR; sequencing) to characterize edited genes and to evaluate changes in genomic DNA as well changes in RNA abundance of gene-edited tissues.
Design bioanalytical strategies and utilize analytical capabilities to troubleshoot challenging immunoassays/cell-based assays. Conduct sample analysis and data review in support of gene therapy studies in a GLP/GCP-compliant laboratory.
Interpret large data sets using statistical methods and visual tools.
Compose method qualification/validation protocols/reports, sample testing plans, bioanalytical reports and Standard Operating Procedures.
Facilitate method-transfer, validation, sample analysis and report generation. Coordinate resources and timelines for various testing center activities by communicating with principle investigators and collaborating researchers.
Summarize toxicity/biomarker data and present bioanalytical results to the testing team and collaborating groups.
Understand the latest literature and lab technologies as they apply to responsibilities of the testing center.
Keep abreast of regulatory guidance and implement into bioanalytical practices. Train and supervise junior members in the testing center.
The Senior Research Associate is expected to perform duties independently or with minimal oversight.
M.S. or PhD in Biological Sciences or related field with 5-10 years relevant experience in conducting toxicity studies, diagnostics, immunoassays and/or cell-based assays.
Cover letter and Resume
Skills Desired (one or more of the following):
Strong background in immunochemical and cell-based assays, including experience with soluble immunoassays (e.g. ELISA, Luminex), multicolor flow cytometry, cell culture techniques, and general knowledge of antibodies and immunoassays.
Experience with ex vivo analysis of immune cells by flow cytometry and required.
Familiarity with pharmacokinetics, anti-drug/reagent antibody assays, and biomarker testing.
Experience collecting and working with fresh, frozen and fixed biological samples (tissues, serum and plasma).
Familiarity of GLP regulations and regulatory guidance.
Familiarity with Automation platforms.
Familiarity with spreadsheets, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, SAS, etc.).
Detailed oriented, good documentation, technical writing and verbal communication skills.
Ability to multi-task and work in a team environment.
This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, and educational fee discounts. For additional information on University benefits, please visit the Faculty & Staff Benefits website at http://www.umsystem.edu/totalrewards/benefits
The University of Missouri is fully committed to achieving the goal of a diverse and inclusive academic community of faculty, staff and students. We seek individuals who are committed to this goal and our core campus values of respect, responsibility, discovery and excellence.
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