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  • BARDA Medical Diagnostics Subject Matter Expert - Washington - BryceTech

    BryceTech
    BryceTech Washington

    1 week ago

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    Description

    Job Description

    Background:

    The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.

    Together with its industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.

    The Medical Diagnostics SME will produce deliverables that include work products related to the evaluation and management of development, validation, and manufacturing of medical device systems, reagents, and devices, including diagnostics that leverage pathogen and host information and therapeutic devices.

    Job Responsibilities:

    • Serve as the primary interface with BARDA and industry senior leadership on medical diagnostics matters.
    • Provide strategic and technical direction to BARDA's efforts to develop innovative treatments, diagnostic devices, and preventive measures that address threats posed by infectious diseases.
    • Serve as a reliable resource of technical counsel to BARDA and to companies that receive BARDA funding.
    • Coordinate with program managers, scientists, and other subject matter experts as required.
    • Provide an interface between the government, operational staff, and BARDA's industry partners.
    • Apply an extraordinary degree of ingenuity, creativity, and resourcefulness in the development, application, evaluation, and development of advanced technologies, scientific principles, theories, and concepts to ensure the appropriate development of medical countermeasures against infectious agents.
    • Responsible for technical problem solving, data analyses, documentation of procedures and results, performing audits, and writing progress and final reports about medical countermeasures that address infectious diseases.
    • Serve as scientific and technical representative to the Contracting Officer (CO) and Technical Project Officer (PO) concerning the evaluation and development of medical diagnostics against infectious diseases.
    • Assess and monitor the risks associated with clinical development of medical diagnostics against infectious diseases.
    • Render technical opinions to the PO/CO.
    • Review for technical correctness and give expert analysis regarding documents generated by BARDA contractors and federal employees.
    • Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones.
    • Perform site visits/audits with PO/CO (or designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements.
    • Inform PO/CO of any increase/decrease in risk to success of the project and generate contingency risk reduction plans.
    • Assist in contract negotiations on technical matters, as requested.
    • Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA's strategic position within the community developing infectious disease medical countermeasures.
    • Independently perform activities consistent with established organizational practices, precedents, policies, and strategic objectives set forth by BARDA management.
    • Perform analytical, interpretive, evaluative, and/or constructive thinking. Where appropriate or required, develop new methods and processes.
    • Make use of critical human relations skills to understand, select, develop, lead, motivate, and educate others both internal and to create teaming partnerships.
    • Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
    • Participate as subject matter experts on Program Coordination Teams (PCTs).
    • Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.
    • Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
    • Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
    • Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work. Make suggestions on ways to improve those statements of work.
    • Experience distilling complex information into informative and concise summaries.
    • Provide risk/benefit analyses and balanced recommendations.
    • Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space.
    • Provide recommendations for project development level portfolio management and oversight as required.
    • Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.

    Qualifications:

    • At least ten (10) years of relevant industry experience.
    • PhD in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Masters or Bachelors (with commensurate industry experience) of science in a physical science field (engineering, physics, computer science, or similar scientific specialization).
    • Commercial experience developing or manufacturing molecular or immunoassay diagnostic components or systems.

    BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

    Additional Information:

    This position will most likely be 100% remote.

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