Scientist II - Diagnostics & Countermeasures Branch

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; Silver Spring (MD); On-site; USD 93,000 - 105,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Health Savings Account

Retirement plans

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. seeks a Scientist II to lead the RAD group at WRAIR in Silver Spring, MD, advancing FDA-cleared platforms and LDAs for infectious pathogens.

You will validate assays, develop SOPs, ensure compliance, and mentor staff in assay design and validation. Join a multidisciplinary team collaborating with US military, government agencies, academia and international partners to deliver diagnostic and vaccine research that

Qualifications

• ASCP or equivalent certification is required.
• PhD with 5–8 years of relevant experience preferred.
• Experience leading assay development and validation in regulated labs.

Responsibilities

• Oversee design, development, evaluation and implementation of serological and molecular assays for pathogen detection.
• Evaluate assays for clinical laboratory and clinical research use; optimize performance.
• Prepare validation/verification plans and ensure regulatory compliance (FDA/CAP/CLIA).
• Establish SOPs including QC for test reagents per CAP/CLIA/FDA standards.
• Mentor junior scientists and coordinate collaborations with partners.
• Prepare reports, abstracts, and manuscripts for dissemination.

Skills

ASCP certification

Molecular assay development

NGS / bioinformatics

Regulatory knowledge (FDA/CAP/CLIA)

Technical leadership

Communication skills

Project management

Laboratory operations

Data analysis

Validation planning

Education

Doctoral Degree in a science related field

Tools

Real-Time PCR

Digital Droplet PCR

NGS workflows

CLIA regulatory tools

Job description

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 (CRADAs) and Material Transfer Agreements (MTAs) and assist with intramural and extramural applications for programmatic funding.
• Mentor and train clinical and clinical research personnel, to include junior scientists, postdoctoral fellows, and technical staff, in execution of LDA and new/novel test systems.
• Coordinate implementation of new initiatives with DCB Senior Leadership and professional staff within DCB. Prepare new project concept sheets and appropriate budgets and participate in DCB, WRAIR meetings and seminars.
• 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.

Supervisory Responsibilities

• Assigned Lead: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations.

Education and Experience

• Doctoral Degree in a science related field required.
• Minimum of 5-8 years experience required.

Required Knowledge, Skills and Abilities

• ASCP or equivalent certification is required.
• Ability to rapidly change focus/ projects and meet short suspense deadlines is a must.
• Knowledge of serological and molecular biological and next generation sequencing (NGS) and bioinformatics skills/techniques used in research laboratories.; highly skilled in the design 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, to include generation of validation and verification plans, business case analysis, research 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.
• This position requires that you obtain and maintain a T1/Public Trust background check.

Physical Capabilities

• Lifting: Requires lifting materials up to 25 lbs.
• Ability to stand or sit at a computer for prolonged periods

Work Environment

• This position will take place primarily in a laboratory setting.

Compensation

• The annual salary range for this position is $93,100-$105,000. Actual salary will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.