Research Associate II - Clinical PD Biomarkers Program

PROGRAM DESCRIPTION The Frederick National Laboratory for Cancer Research (FNLCR) is a Federally Funded Research and Development Center sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. With more than 2,000 employees, the FNLCR is responsible for pursuing its public health service mission via translational and applied biomedical research that is unique from academia, the pharmaceutical industry, or other federal contractors. There are excellent opportunities and support for collaborative research programs within the FNLCR and between the FNLCR and the NCI in developmental therapeutics, pharmacology, cancer genomics, computational biology, preclinical imaging, natural products, veterinary oncology, and solid and hematological malignancies and their preclinical models (including rare diseases and early passage patient-derived models). Outstanding core laboratories and an unparalleled environment for collaborations among basic, translational, and clinical scientists foster interdisciplinary research and translation of discoveries from the lab into the clinic. The selected candidate will join the Clinical PD Biomarkers program, located at the NCI-Frederick campus. The Clinical PD Biomarkers Program is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute. The scope of work includes assay design, development, validation, fitness for purpose testing, transfer of assays to clinical laboratories, and clinical specimen analysis when required. The program facilitates mechanistic evaluation of putative anti-cancer agents, diagnostic tests, and therapeutic interventions to facilitate clinical entry, including distinct molecular signatures for cancer, refined molecular assays, and state-of-the-art imaging techniques that are too high-risk for industry or academia to pursue. The program operates a number of advanced, specialized instrumentation for measurement of multiplexed biomarkers, image analysis of tumor biopsies, circulating tumor cells, and activated T-cells for measuring drug effects in patients enrolled in phase 0 and 1 clinical trials. KEY ROLES/RESPONSIBILITIES Develops multiplex immunoassays of de novo pharmacodynamic biomarkers on Luminex platform, write “standard operating procedures” (SOPs), performs analytical validation of assays, process assay data by appropriate data reduction and statistical methodologies and implement PD biomarker assays in preclinical and clinical studies. Independently perform complex assignments associated with all aspects of immunoassay development, method validation, data analysis and implementation. Perform tissue culture experiments using cancer cell lines to demonstrate utility of pharmacodynamic biomarkers of investigational agents. Troubleshoot day-to-day activity on multiplex immunoassays to meet/ensure required performance. Prepare and characterize reagents required for immunoassay development (antibody conjugates, calibrators, stabilizers etc.) to support Luminex assays for clinical and preclinical testing. Design and prepare quality control materials from tumor models, animal tissues and cancer cell lines and qualify them for biomarker assays. Prepare progress reports for management, maintain all work-related documentation and deliver accurate, traceable results to the program leaders. BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Bachelor’s degree in science, bioinformatics, or a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA), or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirement, a minimum of five (5) years of laboratory experience including at least two (2) years experience in immunoassay development of biomarkers. Experience in techniques used in immunoassay development such as SDS-PAGE, Western blotting, antibody characterization, conjugation of proteins, protein purification, and cell culture. Experience in preclinical biomarker analysis. Ability to independently design and conduct experiments, process quality control data, and process results into presentable scientific reports. Ability to obtain and maintain a security clearance. PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Experience or knowledge in bioinformatics, lab automation, chemical biology or analytical chemistry. Experience in immunoassay development or analytical method development and validation on a multiplex platform. Demonstrated ability to independently design and conduct experiments, organize work, process experimental data, and generate appropriate reports / presentations. JOB HAZARDS This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations.