BARDA Senior Biological Subject Matter Expert

Company Description

BryceTech. BryceTech has partnered with technology and R&D clients to deliver mission and business success for nearly 20 years. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision making. Bryce cultivates a culture of engagement and partnership with our clients. Bryce Space and Technology is an Equal Opportunity Employer.

BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.

Job Description

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) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: 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 (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.

Senior Biological Subject Matter Expert Specific Responsibilities.

Deliverables would include:

• Threat landscape assessments
• Tracking viral evolution over time and space and impact of evolution on effectiveness of medical countermeasures
• General reports on new and emerging pathogens and other threats epidemiology, potential MCMs, etc.
• Evaluation of existing and new technologies and how they could be integrated into development of BARDA supported MCM
• Review and assess a variety of documents for TEPs, PCTs, and other groups in the context of basic and applied biology and innovative technology, particularly as they relate to MCM development.
• Expert ability to deliver work products related to the development and management of programs within current and planned BARDA biological threat medical countermeasures advanced development and acquisition contracts.
• Provide guidance to less experienced staff, reviews the work of others, authoritatively contributes to multi-functional analytic teams, and maintains currency in understanding relevant WMD technologies, trends, and procedures.
• Create work products related to the development of programs within current and planned BARDA biological chemical threat medical countermeasures advanced development and acquisition contracts.
• Coordinate with program managers, scientists, and other subject matter experts as required.
• Serve as a technical authority with a focus on current/near-term events, plans, developments, and trends pertaining to the proliferation of WMD and biological events; issues impacting biological security; force protection; and force operability and survivability against a broad spectrum of biological WMD events.

Qualifications

• Graduate degree in biological related field (biology, microbiology, epidemiology, public health, immunology, molecular biology, etc) with commensurate research and development experience in viral and/or bacterial threats including biothreats (biosafety/biosecurity) and public health threats.
• Fifteen (15) years’ experience with CBRN/WMD-related intelligence (to include counter-proliferation, pandemics, health/medical, biological preparedness, weapons technology, etc.)
• Experience with the terminology used in the collection of data for chemicals, biologics, and WMDs and their proliferation.
• Deliverables would include work products related to understanding the interplay between these threats, new technologies, and MCMs in the BARDA relevant landscape.
• Experience in assessing basic pathogen biology and potential countermeasure targets, latest biological trends, and innovations that could drive new innovative medical products and therapeutic and vaccine technologies.
• Federal or industry experience desired.
  

Additional Information

This position will most likely be 100% remote.