Join the HJF Team!
Henry M. Jackson Foundation (HJF) is seeking a dynamic and experienced Staff Scientist to lead 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 position is within the Department of Laboratory Diagnostics and Monitoring (DLDM), US Military HIV Research Program (MHRP), Walter Reed Army Institute of Research (WRAIR) located in Rockville, MD. 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 vaccine, therapeutic, and or cure 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.
Oversee the design, development, evaluation and implementation of assays to include serological immunoassays and molecular assays Real-Time, Digital Droplet PCR, and next generation systems 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 plans and summaries in accordance with CAP/CLIA/U.S. FDA regulatory requirements 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 assistance for DLDM intramural and extramural collaborators as required.
Train clinical and clinical research personnel in execution of LDA and new/novel test systems.
Coordinate implementation of new initiatives with DLDM Senior Leadership and professional staff within DLDM. Prepare new project concept sheets and appropriate budgets.
Assist with intramural and extramural applications for programmatic funding.
Prepare written reports, abstracts for submission to scientific conferences, manuscripts for submission to scientific journals, Material Transfer Agreements, Cooperative Research and Development Agreements, budgets, and grants.
Participate in DLDM, MHRP, WRAIR meetings and seminars.
Maintains a safe work environment.
Completes all required HJF, WRAIR Safety, HIPPA, CITI, and other required training within specified time frames.
Provides collaborative assistance to other Research Scientists that require the incumbent's expertise.
May require international travel.
Performs other duties as assigned.
Required Knowledge, Skills, and Abilities: Knowledge of serological and molecular techniques used in clinical and clinical research laboratories; highly skilled in the design of primers/ probes, performance of real-time PCR assays; Experience with next generation and Sanger sequencing, DNA sequence analysis and design of primers and probes in support of molecular assay development and validation; and use of peptides, monoclonal antibodies and detection reagents in serological methods for detection of infectious pathogens. Ability to oversee implementation and execution of high complexity assays, troubleshoot technical procedures, prepare and execute clinical validation studies and train and supervise technical staff. Excellent communication skills including preparation of research plans and proposals, technical reports, and manuscripts for submission to scientific journals. Proven ability to work independently and as a member of a multidisciplinary team. Proven ability to present scientific findings as shown by first author publications and oral presentations at scientific meetings.
Minimum Education/Training Requirements: PhD with at least 4 years of research experience in molecular biology, to include principles of development/execution of quantitative molecular assays and clinical applications; experience with serological immunoassays/confirmatory assays a plus.
Physical Capabilities: Job performance requires ability to move around and between several laboratory areas located at 503 Robert Grant Avenue, 9100 Brookville Road, Building 508, Silver Spring, MD 20910, and 13 Taft Court, Rockville, MD. The individual must be able to work in a Biological Safety Cabinet for handling of infectious agents and performance of various assays and techniques. Fine motor coordination in manipulation of laboratory materials and attention to detail is essential. The individual must be able to sit for lengthy periods to include, but not limited to processing of specimens, performing technical analysis at instrumentation, and data analysis at the computer terminal.
Supervisory Responsibilities/Controls: Will be required to work as a member of a team within the Technology Assessment Laboratory, Clinical Evaluation Unit, HIV Diagnostic and Reference Laboratory, and Leishmania Diagnostic Laboratory.
Work Environment: Laboratory environment; may require working evenings and weekends; will involve working with biohazardous materials to include but not limited to, HIV, HBV, HCV, Sexually Transmitted Infections, other Blood Borne Pathogens.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.