Medical Diagnostics SME

Overview:

LMI is seeking a Medical Diagnostics SME to support the Biomedical Advanced Research and Development Authority (BARDA). 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. This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.

The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.

LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.

LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• 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, including
• Provide risk/benefit analyses and balanced recommendations.
• Participate and aid in strategic discussions, working with USG, inbuilding 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.

• Minimum of 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.
• Ability to obtain a public trust clearance. You must be a U.S. citizen.