Senior Chemical SME | Healthcare and Life Sciences [HHS112017]
Core
Senior Chemical SME providing subject matter expertise and advisory support for medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, including research, development, and regulatory approval of diagnostics, vaccines, and therapeutics.
Role type
Senior IC subject matter expert (chemical threats & medical countermeasures)
Builds
Medical countermeasures (diagnostics, vaccines, therapeutics) and strategic program alignment for BARDA
Domain
Healthcare and Life Sciences / Biopharmaceuticals / CBRN Defense
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medicinal chemistry, preclinical development (pharmacology, toxicology), advanced clinical development, regulatory policy, CMC, process scale-up, aseptic manufacturing, Total Life Cycle Cost (TLCC) management, market research, cost estimation, risk/benefit analysis
Preferred skills
Experience with plastic consumable design, reliability engineering, assay chemistry, microbiology, virology, immunology, sterile facility operations
Technologies
None explicitly listed
Responsibilities
Serve as advisor on Technical Evaluation Panels (TEPs) and Program Coordination Teams (PCTs), review study protocols and regulatory documents, develop expert summary reports and technical assessments, advise federal staff on project development and portfolio management, provide recommendations for Total Life Cycle Cost efforts
Seniority
Senior, hands-on IC