Senior Vaccine and Biologic Development SME | Healthcare and Life Sciences [HHS127032]
Core
Senior Subject Matter Expert providing advisory support for the research, development, manufacture, and regulatory approval of medical countermeasures (vaccines, biologics, therapeutics) against CBRN threats and emerging infectious diseases for BARDA.
Role type
Senior IC Subject Matter Expert (Vaccine and Biologic Development)
Builds
Medical countermeasures including diagnostics, vaccines, and therapeutics for public health emergencies
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Medical Countermeasures
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory studies and licensure programs, Preclinical development (animal models, pharmacology, toxicology), Advanced clinical development, Manufacturing scalability and capacity expansion, Sterile manufacturing and aseptic techniques, Process development and scale-up, Data analysis for regulatory submissions, Risk-benefit analysis
Preferred skills
Medicinal chemistry, Immunology, Virology, Microbiology, Device development, Total Life Cycle Cost (TLCC) management
Technologies
None explicitly listed
Responsibilities
Serve as advisor on Technical Evaluation Panels (TEPs) and Program Coordination Teams (PCTs), 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, Provide guidance on regulatory strategies and manufacturing processes
Seniority
Senior, hands-on IC
