The Clinical Pharmacodynamic (PD) Biomarker 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 of the project that has this opening involves: 1) development of highly specialized protein extraction and tissue-handling methodologies for brain tumor (CNS tissue) specimens to preserve labile biomarkers (eg, phosphoproteins); and 2) development, validation and fit-for-purpose demonstration of PD biomarker assays in clinical specimens and laboratory models (eg, spontaneous brain tumors in human patients, PDX models, in vitro neurospheres, etc.), (3) application of validated PD biomarker assays to the analysis of brain cancer specimens to understand therapeutic response and resistance, including analysis of clinical trial biopsies, and (4) application of validated PD biomarker assays to the analysis of other unusual/rare cancer types for which therapeutic response is poorly understood. The program uses biomarker assays that meet or exceed clinical assay performance standards to provide mechanistic understanding of experimental and investigational anti-cancer agents and their optimal use that dovetails with other clinical applications, including distinct molecular signatures for cancer, refined molecular assays, and state-of-the-art imaging techniques. KEY ROLES/RESPONSIBILITIES The Research Associate II will be responsible for adapting validated methodology for the extraction and measurement of PD labile biomarkers to their analysis in malignant CNS tissue and pertinent experimental models. PD biomarker analyses will utilize validated assays on both immunoassay and microscopy platforms. Specific duties include: Develop procedures to preserve protein biomarkers and their post-translational modification in freshly-acquired clinical specimens from brain tumor patients enrolled in NCI-sponsored clinical studies to implement currently validated PD biomarker assays. Develop effective procedures for extraction of labile protein biomarkers from brain tumor specimens ensuring maximum solubilization, recovery, stability and accurate quantitation of protein biomarkers of interest, many of which will be post-translational modifications. Implement/adapt currently validated PD Biomarkers for the analysis of CNS biopsy specimens collected before and after drug treatment Perform ELISA and multiplex assays of de novo pharmacodynamic biomarkers on Luminex platform, write "standard operating procedures" (SOPs), performs 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 aspects of immunoassay validation, processing of biopsy samples for immunoassays analysis, and data interpretation and presentation Perform Luminex assays on semi- or fully-automated platforms. Requires knowledge about integration of liquid handling systems with peripherals such as orbital plate shakers, plate chillers, magnetic plate washers, multi-label ELISA readers, and Luminex readers Train others on techniques in multiplex immunoassay and perform SOP based inter-laboratory transfer of PD biomarker assays Prepare and characterize key reagents (antibodies, conjugates, calibrators, stabilizers, etc.) to support Luminex assays for clinical and preclinical analysis of brain specimens. Characterize critical reagents using affinity purification, immunoblotting, and spectral analysis. Prepare quality control materials from xenograft tumor models, animal tissues and cancer cell lines and qualify them for different PD biomarker assays Responsible for general lab upkeep to ensure compliance with relevant NCI safety regulations and Leidos corporate policies. Ensures that instruments/safety-cabinets are in compliance with QC requirements and preventive maintenance is performed in timely manner BASIC QUALIFICATIONS Possession of an Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for US equivalency. In addition to educational requirements, a minimum of five (5) years related biomedical experience which should include at least four (4) years of laboratory experience in immunoassay development and implementation of Luminex multiplex assays on tumor tissue specimens Experience in techniques used in immunoassay development such as SDS-PAGE, Western blotting, antibody characterization, conjugation of proteins, protein purification, and cell culture Scientific background in biomarker analysis and in neuroscience or other biomedical field related to the study of the brain At least 2 years of experience in processing solid tumor samples for analysis of labile protein biomarkers Demonstrated ability to operate semi- or fully-automated laboratory developed tests. Experience in integration of high precision liquid handling system with peripherals such as orbital plate shakers, plate chillers, plate washers, multi-label ELISA readers, and Luminex readers. Proficiency in writing SOPs. Should be able to independently design and conduct experiments, process quality control data, and process results into presentable scientific reports under oversight by a senior scientist Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Experience with the analysis of protein endpoints or biomarkers in brain or brain tumor specimens, or laboratory models High level Experience in multiplex immunoassay development using the Luminex platform Experience in implementation of PD biomarkers for fit-for-purpose studies using tumor tissues Expected Competencies Able to independently design and conduct experiments, organize work, process experimental data, and generate appropriate reports / presentations Experience in methodologies of tumor tissue handling, processing, and protein extractions for analysis of labile protein biomarkers Experience in methodologies involved in multiplex immunoassay development, antibody/protein characterization, and cell culture Skills in set up, care and use of laboratory equipment (liquid handling systems and Luminex readers) and improving methodology Ability to identify and trouble shoot multiplex immunoassay problems and implement corrective actions Computer skills (including proficiency in Microsoft Office programs), knowledge about computer languages, ability to perform basic laboratory math including some knowledge of basic statistical methodologies Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)