Full-Time BARDA Business Development SME

General SME Responsibilities:Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) and the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats. Includes diagnostics, medical devices/infrastructure, vaccines, and therapeutics.

Desired Experience: medicinal chemistry, preclinical development (animal models, pharmacology, toxicology), advanced clinical development (medical officers, immunologists, clinical operations), analytical product testing and testing development, quality control, clinical and/or regulatory policy, and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology, Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities.

Specific Responsibilities: Provide guidance, recommendations, and advisory support to Technical Evaluation Panels (TEPs) and Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and educational material to PCT and COR. Provide subject matter expertise to federal staff for cost estimates, review and comment on documents, develop work products, and advise on Contractor statements of work.

Business Development & Investment/Commercialization Responsibilities: Serve as business development, investment, and commercialization expert. Evaluate white papers, market research, business strategies, and plans. Provide expert opinion, analysis, assessment, guidance and recommendations. Serve as BARDA’s knowledge source. Provide strategic input to program managers on public-private partnerships. Provide evaluative feedback on business and commercialization plans.

Additional Requirements: At least 10 years of experience in the life sciences industry. Entrepreneur experience founding multiple companies, raising funds, and leading to successful outcome (M&A or IPO) or Pharma/MedTech business development executive with M&A experience, or Venture/Private equity investment with board member or observer experience. Graduate degree in biomedical sciences/healthcare preferred.

Benefits: Competitive salary, comprehensive health plan (dental and vision), life & disability insurance, 401(k) plan with company match, educational reimbursement program.

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