Full-Time BARDA Senior Biological Subject Matter Expert

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).Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development; advanced clinical development; analytical product testing; quality control; clinical and/or regulatory policy; manufacturing. 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. Provide guidance and recommendations on key issues.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.Provide subject matter expertise and advisory support to federal staff for development of cost estimates.Review and comment on study protocols, study reports, regulatory documents, presentations, proposals.Develop work products (expert summary reports, expert opinion assessment reports, analysis reports). Advise federal staff on the appropriateness and 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 summaries, including risk/benefit analyses and balanced recommendations. Participate and aid in strategic discussions, working with USG, in building new program areas. Provide recommendations for project development level portfolio management and oversight. Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.

Senior Biological Subject Matter Expert Specific Responsibilities: Deliverables would include: Threat landscape assessments. Tracking viral evolution. Evaluation of existing and new technologies.Review and assess a variety of documents.Expert ability to deliver work products related to the development and management of programs.Provide guidance to less experienced staff, reviews the work of others, authoritatively contributes. Coordinate with program managers, scientists, and other subject matter experts.Serve as a technical authority.Graduate degree in biological related field (biology, microbiology, epidemiology, public health, immunology, molecular biology).Fifteen (15) years’ experience with CBRN/WMD-related intelligence (counter-proliferation, pandemics, health/medical, biological preparedness, weapons technology).Experience with the terminology used in the collection of data for chemicals, biologics, and WMDs and their proliferation.Experience in assessing basic pathogen biology.Federal or industry experience desired. This position will most likely be 100% remote.

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