Scientist II - Diagnostics & Countermeasures Branch

Join the HJF Team!

HJF is seeking a Scientist II to lead the RAD group in the development and/or evaluation, validation, and implementation of U.S. FDA approved/cleared platforms/assays, laboratory developed tests, and next generation methodologies for detection of infectious pathogens of US Military and National interest. The incumbent will be expected to apply a wide variety of scientific principles and concepts to support clinical laboratory service delivery and clinical research initiatives focused on diagnostic, therapeutic, cure and or vaccine research for prevalent and emerging pathogens.

The incumbent will work within a multidisciplinary environment and teams encompassing US Military, US Government Agencies, Foreign Militaries, Non-Profit Organizations, Academia, and International Scientific collaborators.

This position will be in support of the Research, Assessment and Development laboratory (RAD) in the Diagnostics and Countermeasures Branch (DCB), within the Center for Infectious Disease Research (CIDR) at the Walter Reed Army Institute of Research (WRAIR) located in Silver Spring, MD.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners.

HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• Oversee the design, development, evaluation and implementation of assays to include serological immunoassays and molecular assays such as Real-Time, Digital Droplet PCR, and next generation sequencing for detection and/or quantification of infectious pathogens in a variety of specimen matrices.
• Evaluate assays for acceptable use for clinical laboratory, clinical research, and/or public health evaluations; modify as required for optimal performance to achieve desired sensitivity, specificity, reproducibility, etc.
• Prepare validation and/or verification plans and summaries and ensure all clinical and clinical research is performed and documented in compliance with applicable regulatory and quality practices (e.g., FDA, CAP/CLIA, CLSI, CDC, U.S. FDA), to include preparation of all documents for the performance of the test system and associated reagents.
• Establish Standard Operating Procedures to include quality control procedures for all reagents used in the test system in accordance with accrediting body and U.S regulatory agency standards (CAP/CLIA/U.S. FDA) for execution within clinical laboratories conducting high complexity testing and in support of vaccine, therapeutic, and cure research initiatives.
• Assess, validate and verify the performance of Laboratory Developed Assays (LDAs) to meet regulatory compliance for testing of human and/or animal biological specimens used to inform patient management or end point analyses for clinical research studies
• Coordinate and conduct technology assessments for novel assays and instrumentation to advance infectious disease diagnostic and monitoring capabilities of DCB.
• Help identify and implement intramural collaborations with other Military HIV Research Program/WRAIR investigators in pursuit of various epidemiologic, clinical, vaccine and cure initiatives.
• Assist with setting up collaborations with other governments, academic or industry researchers including drafting Cooperative Research and Development Agreements…