Background: The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks; pandemic influenza (PI), and emerging infectious diseases (EID).Together with its industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.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.Responsibilities specific to Human Factors and Social Science:Serve as the subject matter expert focused on human factors, user experience, human-centered design, social factors, and equity and access for development and adoption of medical countermeasures. Provide strategic insight on usability, human factors, patient experience etc with BARDA funded medical countermeasures. As requested, provide insight and recommendations to BARDA programs on how to more strategically integrate user feedback into BARDA programs. Review and provide expert feedback on clinical protocols, surveys etc that explore participant, patient and user experiences. Contribute and facilitate development efforts as a PCT member, serving as a SME on the above areas for BARDA funded efforts.
