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.

Specific BD and Investment/Commercialization Responsibilities:

• Serve as business development, investment, and commercialization expert and strategic advisor to government program team to include evaluation of white papers/market research and corresponding business strategies and plans.
• Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert opinion, analysis, assessment, guidance and recommendations.
• Serve as BARDA’s knowledge source for educational purposes in this area, providing background and learning material, as well as 1:1 support as needed.
• Provide subject matter expertise and advise to DRIVe portfolio companies across all funding mechanisms.
• Provide strategic input and expert opinion to program manager(s) on public-private partnerships to support Ventures and other MCM innovation ecosystems development.
• Provide general technical/product development and business/commercialization expertise and advice.
• Provide evaluative feedback on business and commercialization plans of applicants and partners.
• Provide general business/commercialization advise and ad-hoc mentorship especially to BARDA Ventures, Blue Knight, BARDA Accelerator Network, and DRIVe portfolio companies.

Qualifications

• At least 10 years of experience in life sciences industry.
• Entrepreneur with experience founding multiple companies, raising funds, and leading to successful outcome (i.e., M&A or IPO) and/or:
  • Pharma/MedTech business development executive that has led multiple M&A transactions and/or o Venture/Private equity investment with experience as board member or observer providing hands on support to portfolio companies.
• Graduate degree in biomedical sciences/healthcare preferred.
• Understanding of life sciences/medical countermeasures (MCM) product development life cycle, business development, and commercialization.

Additional Information

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.

All your information will be kept confidential according to EEO guidelines.