Scientist I Job ID: req1543 Employee Type: exempt full-time Facility: Frederick: Ft Detrick Location: PO Box B, Frederick, MD 21702 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest. Position Overview: PROGRAM DESCRIPTION The Frederick National Laboratory for Cancer Research (FNL) is a Federally Funded Research and Development Center sponsored by the National Cancer Institute (NCI) and operated by the prime contractor Leidos Biomedical Research, Inc. FNL is responsible for pursuing a unique mission in translational and applied biomedical research that is unsuitable for academia, the pharmaceutical industry, or other federal contractors. This open position in is ideally suited for a scientist who is more interested in applied Research & Development than in performing basic research. 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 NCI. 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 * Responsible for pharmacodynamic multiplex immunoassay development, validation, and analysis of cancer agent activity in preclinical and/or clinical specimens * Develop multiplex immunoassays of de novo pharmacodynamic biomarkers on Luminex platform, write "standard operating procedures" (SOPs), perform analytical validation of assays, process assay data by appropriate analysis and statistical methodologies and implement PD biomarker assays in preclinical and clinical studies * Independently perform complex assignments associated with all aspect of immunoassay development, validation, data analysis and implementation * Troubleshoot day-to-day activity on multiplex immunoassays to meet/ensure required performance * Design biomarker driven preclinical pharmacodynamic studies * Train lab personnel on techniques in multiplex immunoassay and perform SOP based inter-laboratory transfer of PD biomarker assays * 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 * Possession of PhD degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research. Foreign degrees must be evaluated for US equivalency * No work experience required with a PhD degree * Computer skills, knowledge about computer languages, ability to perform basic laboratory math including some knowledge of basic statistical methodologies * Able 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 * 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 pharmacodynamic biomarker analysis * Two or more years of experience in immunoassay development and validation of biomarkers on Luminex platform * Demonstrated ability to independently design and conduct experiments, organize work, process experimental data, and generate appropriate reports / presentations * Demonstrated experience in monoclonal antibody development and protein chemistry * Demonstrated experience in multiplex analytical methods and validation process * Knowledge of clinical trial designs and regulatory aspects * Experience in clinical specimen testing of tissues and cells * Possess skills in setting up, care and use of laboratory equipment (liquid handling systems and Luminex readers) and ability to improve a methodology * Ability to identify and trouble shoot multiplex immunoassay problems and take corrective actions JOB HAZARDS * This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations * This position is subject to working in or have the potential to exposure to high noise levels for extended periods of time requiring medical clearance Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) #readytowork