Senior Drug/Vaccine/Diagnostic/Clinical Development SME | Healthcare and Life Sciences [HHS116021]
Core
Senior Subject Matter Expert providing technical advisory and program support for the development, manufacturing, and regulatory approval of medical countermeasures (vaccines, therapeutics, diagnostics) against CBRN threats and emerging infectious diseases.
Role type
Senior IC Clinical Development & CMC SME
Builds
Medical countermeasures, vaccines, therapeutics, and diagnostics for public health emergencies
Domain
Biopharmaceuticals / Medical Countermeasures / CBRN Defense
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics development, CMC expertise, drug formulation, process development, regulatory affairs (IND/BLA), quality control, sterile manufacturing, technology transfer, risk/benefit analysis
Preferred skills
Medicinal chemistry, preclinical development, clinical operations, microbiology, virology, immunology, manufacturing scalability
Technologies
None explicitly listed
Responsibilities
Serve as advisor on Technical Evaluation Panels and Program Coordination Teams; Review and comment on study protocols and regulatory documents; Develop expert reports and technical assessments; Advise federal staff on program success probability and cost estimates; Provide recommendations for portfolio management and Total Life Cycle Cost efforts
Seniority
Senior, hands-on IC