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 Vaccine and Biologic Development Subject Matter Expert Specific Responsibilities.Apply expert ability to deliver work products related to the development and management of regulatory studies and licensure programs within current and planned BARDA vaccine and biologic development and acquisition contracts.Supervise less experienced Vaccine and Biologic Development Subject Matter Experts.Serve as the primary interface with BARDA and Industry Senior Leadership on vaccine and biologic drug development.Coordinate with program managers, scientists, and other subject matter experts as required.Serve as a subject matter expert in relevant field of experience(s) for vaccines related to the development, and management of regulatory studies and licensure programs with current and planned BARDA vaccine development and acquisition contracts.Evaluate vaccine candidates for the feasibility of successful advanced development.Evaluate raw data generated from testing and data analyses.Make sound and timely recommendations to facilitate decision-making.Review contract proposal and related documents and provide recommendations to USG.Provide senior-level briefing(s) to ASPR/BARDA as required; prepare regular reports to ASPR/BARDA management on various technical issues identified.Draft briefings that include technical alternatives between competing technologies for USG review.Provide project development-level portfolio management and oversight.Provide support to BARDA’s Production Coordination Teams.Provide and summarize guidance documents and option papers on key issues related to the area(s) identified.Develop milestones, targets, and metrics to support portfolio management, as needed.Accelerate information flow and guidance from senior leaders to the staff to ensure synchronization and unity of effort.Facilitate coordination across entities, with the single goal of providing actionable information and knowledge to enable decision-making by leaders.Serve as the programmatic representative at conferences and stakeholder meetings.Provide scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate medical countermeasures through advanced development, DoD acquisition processes, production, and fielding.Collaborate with both internal and external partners, contributing to data.Engage in open and collaborative communication as a SME, at conferences (e.g., briefings, presentations, etc.) regarding science and technology innovations.Develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).Prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.Develop drafts and assist the project team to coordinate responsibilities, oversee quality and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.Assist to identify and assess risks of new technologies and ongoing projects.
