Full-Time BARDA Vaccine & Biologic SME

Background: BARDA was established in 2006 to develop vaccines, therapeutics, diagnostics, and technologies for public health emergencies. Success is shown by FDA approvals, COVID-19 products supported, and partnerships. This success relies on public-private partnerships to accelerate medical countermeasure (MCM) development.

General SME Responsibilities: Supports BARDA Program Office(s) as a subject matter expert in Chemical, Radiological/Nuclear, Burn/Blast, Biological (viral/bacterial), Influenza, and Emerging Infectious Diseases. Supports research, development, manufacturing, and regulatory approval of MCMs (including diagnostics, medical devices, vaccines, and therapeutics).

Desired Experience: Medicinal chemistry, preclinical development (animal models, pharmacology, toxicology), advanced clinical development (medical officers, immunologists, clinical operations), analytical product testing, quality control, clinical/regulatory policy, manufacturing (chemistry, manufacturing, and controls), process development, device development, reliability engineering, software, assay chemistry, microbiology, virology, immunology, plastic consumable design, manufacturing scalability, sterile/aseptic technique, sterile manufacturing/filling.

Responsibilities (continued): Provides guidance on key issues, serves as advisor on Technical Evaluation Panels (TEPs), participates on Program Coordination Teams (PCTs), provides expert assessments, recommendations, and educational materials. Develops work products (expert reports, analysis reports, manuscript writing), reviews documents (study protocols, regulatory documents, proposals).

Specific Responsibilities (Senior Vaccine & Biologic Development SME): Delivers work related to regulatory studies, licensure programs, vaccine/biologic development/acquisition contracts. Serves as interface with BARDA and industry leadership. Coordinates with program managers, scientists, and other experts. Evaluates vaccine candidates, raw data, and makes recommendations. Reviews contract proposals. Prepares briefings for ASPR/BARDA. Provides project development-level portfolio management.

Skills & Qualifications: Doctoral degree in medicine or pharmacy. 10+ years of relevant experience. 10+ years of industry experience in pharmaceutical/biotechnology advanced development (IND to FDA approval). Experience in pharmaceutical/biotechnology drug development portfolio management, regulatory studies and licensure programs. Experience in guiding and tracking multiple planning lines of effort. Published peer-reviewed articles preferred.

Benefits: Competitive salary, comprehensive health plan, life/disability insurance, 401k with match, educational reimbursement.

Work Location: 100% remote.

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