Background. In 2006 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. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  General SME Responsibilities: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.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. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.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 expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.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 providing 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.Senior Chemical Subject Matter Expert Specific ResponsibilitiesProviding subject matter expertise in fields relevant to the Homeland Security Enterprise, including chemical, biological, radiological, and nuclear subject areas.Monitoring project performance and reviewing deliverables to ensure technical, programmatic, and financial goals and objectives are met and identify possible program risks.Providing support to Portfolio and Program Managers in their continued engagement with DHS S&T customers on the receipt, prioritization, and regular reporting of their operational capability gaps.Providing data collection and analyses of user requirements and of existing and emerging systems, capabilities, and technologies.Performing routine tasks including, but not limited to, scheduling, writing internal memos, maintaining and updating Program Management records, filing, intranet website maintenance, preparing and reviewing presentations, records maintenance, and coordinating daily operations of the assigned program.Assisting with planning technology transitions to the respective operational customer.Attending meetings, workshops, conferences, and program reviews at the direction of the program or project manager to provide programmatic and technical review, record meeting minutes, and contribute to the program management dialogue with performers.Providing assistance in managing and responding to program-aligned S&T Executive Secretary data calls, compiling information, and preparing information for reporting to senior leadership.Supporting the identification, assessment, evaluation, and testing of existing and emerging technologies, systems, and capabilities, including coordination with related government, academic, and industry programs; attending meetings and symposia; coordinating meetings and programs reviews; and supporting program advocacy including development and production of presentation materials.Expert ability to deliver work products related to the development and management of programs within current and planned BARDA chemical threat medical countermeasures advanced development and acquisition contracts.Provides guidance to less experienced staff, reviews the work of others, authoritatively contributes to multi-functional analytic teams, and maintains currency in understanding relevant WMD technologies, trends, and procedures. Devises, evaluate, and recommend new methodologies and analytical tools that are under development. Coordinate with program managers, scientists, and other subject matter experts as required.Routinely provides defense planners and operators with timely and accurate characterizations of adversary chemical threats, WMD programs, and weapons-related S&T developments.Creates work products related to the development of programs within current and planned BARDA chemical threat medical countermeasures advanced development and acquisition contracts.Collaborates with the Intelligence Community, Defense Department, national labs, and academia to address chemical and biochemical threat issues. Performs and leads research, collection, and collation of intelligence information. Performs assessments and projections as part of analysis process.Develops technical reports and briefings, project deliverables, monthly status reports and other finished products.
