BSL-3 Laboratory Specialist ((Microbiology and Immunology) with Security Clearance

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Job description

Position Summary Odyssey is looking for a BSL-3 Laboratory Specialist (Microbiology and Immunology) to support the Molecular Diagnostics Department in the Biological Defense Research Directorate (BDRD) at the Naval Medical Research Center (NMRC). The goal of this group is to broaden the ability of the Directorate to produce quality assays and reagents for the detection of bio-threat agents domestically and across the globe. The mission of the Microbiology and Immunology (MI) and Molecular Diagnostic (MD) departments of Naval Medical Research Command BDRD is to research, develop and produce detection and mitigation products to counter biological threat agents, both natural and man-made domestically and across the globe. Contingent upon contract award Responsibilities Duties include, but are not limited to: Lateral Flow Assay Development & Production (support to MI Department): The contractor shall assist with the development of rapid diagnostic and detection immunoassays for the identification of biological threat agents and emerging pathogens. The contractor shall assist with the production and distribution of lateral flow immunoassays for the detection of biological threat agents and emerging pathogens to the DBPAO and other Federal agencies. The contractor shall provide laboratory support, that will include work in Biosafety Level (BSL)-2 and BSL-3 laboratories and may include work with biological toxins regulated under 42 CFR Part 73. To support this project, assistance with the following specific tasks shall be performed: Develop lateral flow immunoassays against bacterial, viral and biological toxin targets; Produce and distribute lateral flow assays based on customer demands, estimated at 10,000 lateral flow assays per year; Conduct training for lateral flow assay end users. Antibody Production (support to MI Department): The contractor shall assist with the production and distribution of immunological reagents to the DBPAO and other Federal customers. Antibody production is conducted under ISO 17034 Standard in an accredited laboratory for the production of certified reference materials. To meet these production standards, a rigorous Quality Management System is in place that governs the production of polyclonal, monoclonal, and affinity purified polyclonal antibodies. Laboratory support will be conducted in BSL-2 and BSL-3 laboratories to include work with Biological Select Agents and Toxins (BSAT) requiring enrollment in a Biological Personnel Reliability Program (BPRP). To support this project, assistance with the following tasks shall be performed: Produce polyclonal and monoclonal antibodies against a variety of biological threat agents and infectious diseases Produce affinity purified antibodies using antigen materials to include BSAT or BSAT derivatives; Continually improve Quality Management System to meet applicable accreditation standards; and Ensure laboratory operations at BSL-2 and BSL-3 are conducted according to all Federal, DoD, State and local regulations Immunoassay Development and Testing (support to MI Department): The contractor shall assist with the development, production and testing of immunoassays and new immunoassay platforms for various DoD and Federal customers. The contractor shall assist with the transition of immunoassays to customers and use them in-house for conformance testing of antibodies under the Quality Management System prior to distribution. Laboratory support will be conducted in BSL-2 and BSL-3 laboratories to include work with BSAT requiring enrollment in a BPRP. To support this project, assistance with the following tasks shall be performed: Develop and produce immunoassays for the detection of biological threat agents and infectious diseases; Develop and produce immunoassays for conformance testing of purified antibodies; Continually improve Quality Management System to meet applicable accreditation standards; Conduct test & evaluation of current or new immunoassay platforms of interest to DoD and other Federal agencies; Conduct training on antibodies, immunoassay platforms, and immunoassays to end-users domestically and abroad; and Ensure laboratory operations at BSL-2 and BSL-3 are conducted according to all Federal, DoD, State and local regulations. Research and development of biomarkers of neurological injury for encephalitic viruses (support to MI Department): The contractor shall assist with the research and development project aimed at identification of neuromarkers of central nervous system tissue injury. These could serve as biomarkers to assess injury severity, monitor disease progression, direct treatment, and as reliable endpoints to help develop novel medical countermeasures. Laboratory support will be conducted in BSL-2 and BSL-3 laboratories to include work with BSAT requiring enrollment in a BPRP. To support this project, assistance with the following tasks shall be performed: Evaluate confirmed human cases of encephalitis for the presence of the protein biomarkers UCH-L1 and GFAP in the serum. Determine if the protein biomarkers UCH-L1 and GFAP can be detected in non-human primates (NHP) infected with the encephalitic alphaviruses. Expand the effort to include assessments of additional biomarkers and additional human and NHP samples to qualify the use of the assay to diagnose brain injury due to alphavirus infection. Transition the biomarker assay to an appropriate platform and validate the assay. Research and development for emerging infectious diseases (support to MI Department): The contractor shall assist with research and development projects aimed to: 1) discover and characterize viruses associated with emerging infectious diseases; and 2) develop immunomodulatory therapeutics for emerging viruses. These projects involve culturing and characterizing viruses from clinical samples and insect and mammalian vectors. Host specific biomarker analyses will also be completed to characterize the host response and to identify potential countermeasure strategies. Laboratory support will be conducted in BSL-2 and BSL-3 laboratories to include work with Infectious Agent and Toxin or BSAT requiring enrollment in a BPRP. To support these projects, assistance with the following tasks shall be performed: Isolate and quantify virus from human clinical samples, insect, and mammalian samples; Develop and characterize virus stocks; Complete host biomarker analyses; Evaluate immunomodulatory treatments in vitro and in vivo in small animal models; and Develop animal models for evaluation of medical countermeasures and to study pathogenesis. Study virus-host interactions. Field Sample Analysis (support to MD, MI and ELOD Departments): The contractor shall assist with maintaining a capability for analysis of unknown samples to identify suspected biological threat agents. This project includes support to the CDC as a National Laboratory in the Laboratory Response Network (LRN) and support to DoD and other federal customers in unknown sample analysis. The contractor shall provide laboratory support that will include at a minimum, standard microbiological analysis, nucleic acid analysis, and immunological analysis and will include work in Biosafety Level (BSL)-2 and BSL-3 laboratories with BSAT requiring enrollment in a BPRP. The contractor shall provide laboratory support of off-site analysis conducted in field settings or in partner laboratories. To support this project, assistance with the following tasks shall be performed: Conduct unknown sample analysis and proficiency testing as requested and required by the CDC Laboratory Response Network; Conduct on-site and off-site analysis for NMRC (in support the Department of Homeland Security and other Federal entities); Conduct analysis for NMRC and the Department of Defense (CONUS & OCONUS); Conduct unknown sample analysis for Federal law enforcement agencies; and Conduct training and exercises in field sample analysis for DoD and other Federal entities. Contingent upon contract award Qualifications Minimum Required Qualifications Citizenship: Must be a US citizen Clearance: Secret (Able to Obtain) Education: Master's degree/Ph.D. in a biological science field. Years of Experience: 10 years of practical experience conducting microbiology/molecular biology techniques in a BSL-3 laboratory is considered essential Skills: He/she must have demonstrated the ability to operate and sustain a BSL-3 laboratory, including training of other scientists, technicians, and support personnel, writing standard operating procedures/risk assessments, understanding BSL-3 facility requirements, and managing BSAT inventory. The candidate must possess a practical knowledge of basic and applied research and must have demonstrated the ability to perform competent research. The candidate must have at least 5 years of experience working with BSAT and a thorough understanding of Federal and DoD BSAT regulations/instructions. The candidate must have experience working on methods for bacterial growth and detection of bio-threat agents. Must meet all criteria for enrollment in the BPRP. Contractor personnel must be able to travel nationally and internationally for moderate periods of time (up to 2 weeks in length). Additional Information Location: Frederick, MD Travel: up to 20% Remote, Onsite, or Hybrid: Onsite Contingent upon contract award Company Overview Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive

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