Overview In this role you will serve as a senior SME in medical diagnostics within the Healthcare and Life Sciences sector, supporting BARDA-related R&D and regulatory activities. You will advise on diagnostic systems, devices, and reagents, and help translate complex science into actionable guidance for government programs. You will work with cross-functional teams to shape program strategy, assess risks, and support cost estimates and proposals. This is an opportunity to contribute to national preparedness through advanced diagnostics.
Compensation / Benefits- Competitive compensation
- Group health benefits (medical/dental/vision)
- 401(k) with company match
- Vacation and PTO
- Pre-tax benefits and FSAs
- Security clearance eligibility
Responsibilities- Support BARDA Program Office as SME in chemical, radiological/nuclear, biological threats, and infectious diseases diagnostics and related devices
- Provide guidance on development, validation, manufacture, and regulatory licensure/clearance of medical countermeasures
- Lead or participate in Technical Evaluation Panels (TEPs) and Program Coordination Teams (PCTs)
- Develop expert reports, analyses, and proposals; review regulatory documents and study protocols
- Advise federal staff on cost estimates and lifecycle considerations; align projects with BARDA mission
- Support market research, Statements of Work improvements, and strategic portfolio discussions
Key requirements- 10+ years of experience in medical diagnostics or related field
- PhD in life sciences (immunology, molecular biology, microbiology, biochemistry) or Master/Bachelor with relevant industry experience
- Expertise in diagnostics systems, reagents, and device management
- Knowledge of regulatory guidelines for medical devices and compliance experience
- Strong analytical and communication skills for federal/state engagements
- Ability to lead or participate in TEPS and PCTs
- Experience in diagnostic device manufacturing, validation, and lifecycle cost considerations
- strong communication
- analytical thinking
- leadership
- molecular/immunoassay diagnostics
- pathogen-host interaction expertise
- immunology, microbiology, virology knowledge
