Vaccine and Biologic Development SME | Healthcare and Life Sciences [HHS128033]
Core
Subject Matter Expert supporting BARDA in the research, development, manufacture, and regulatory approval of medical countermeasures (vaccines, biologics, therapeutics) against CBRN threats, pandemics, and emerging infectious diseases.
Role type
Senior IC Subject Matter Expert (Vaccine and Biologic Development)
Builds
Medical countermeasures, regulatory submissions, study protocols, and strategic program proposals for BARDA
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Public Health / CBRN Defense
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory studies and licensure programs, Preclinical development (pharmacology, toxicology), Advanced clinical development, Manufacturing and process scale-up, Quality control and testing, Risk-benefit analysis, Technical proposal development, Strategic program alignment
Preferred skills
Medicinal chemistry, Immunology, Virology, Microbiology, Device development, Sterile manufacturing techniques, Total Life Cycle Cost management
Technologies
None explicitly listed
Responsibilities
Serve as advisor on Technical Evaluation Panels (TEPs), Review and comment on study protocols and regulatory documents, Develop expert summary reports and technical assessments, Advise federal staff on cost estimates and program success probability, Participate in strategic discussions to build new program areas
Seniority
Senior, hands-on IC
