Full-Time BARDA Medical Diagnostics SME

BARDA Senior Medical Diagnostics Subject Matter Expert

Background: BARDA integrates the development of vaccines, drugs, therapies, and diagnostics for public health emergencies (CBRN, PI, EID). Collaborating with industry, BARDA advances medical countermeasures to protect Americans.

General SME Responsibilities:

• Support BARDA Program Office(s) as a subject matter expert.
• Provide guidance and recommendations on key issues related to identified areas.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Participate in Program Coordination Teams (PCTs).
• Provide expert assessments and guidance.
• Develop work products (e.g., expert reports, analysis reports).
• Advise on the success probability of contractor proposals.
• Distill complex information into concise summaries (risk/benefit analyses).
• Participate in strategic discussions to build new program areas.
• Provide recommendations for project development and oversight.
• Provide recommendations on Total Life Cycle Cost (TLCC) efforts.
• Participate in market research efforts.

Desired Experience Areas:

• Medicinal chemistry
• Preclinical development (animal models, pharmacology, toxicology)
• Advanced clinical development
• Analytical product testing
• Quality control
• Clinical/regulatory policy
• Manufacturing (chemistry, manufacturing, and controls)
• Device development and manufacturing
• Reliability engineering
• Software
• Assay chemistry
• Microbiology, virology, immunology
• Plastic consumable design
• Manufacturing scalability
• Sterile/aseptic techniques

Education & Experience Requirements:

• 15+ years of relevant industry experience
• PhD in life sciences (e.g., immunology, molecular biology)
• Masters/Bachelors in physical science (with commensurate experience)
• Commercial experience developing/manufacturing diagnostics

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