BARDA Senior Drug/Vaccine/ Diagnostic/Clinical Development Subject Matter Expert

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. 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.Drug/Vaccine/ Diagnostic/Clinical Development SME Specific Responsibilities Oversee & report CMC biologics product development from pre-clinical through full scale.Apply experience with and ability to articulate current working knowledge of the various technical issues associated with bringing a lead candidate through the commercialization process.Apply experience and knowledge of drug formulation.Apply experience in identifying and resolving quality, regulatory, process development or manufacturing technical problems.Knowledgeable in cleaning validation, analytical and manufacturing technology transfer, and process validation.Knowledgeable in analytical methods used to assess drug substance and drug product quality, and specifications development.Ability to determine the most appropriate methodology for the validation of the manufacturing process “Late stage” CMC understanding of regulatory requirements.Apply experience in preparing the CMC sections of INDs and BLAs.Apply experience in auditing biologic drug product manufacturing facilities.Prior experience working in a matrix, teaming environment with team-oriented CMC leadership is essential.Liaise with service providers on a regular basis to monitor progress against milestones, as well as resolve technical, quality or resource issues smoothly.Review and manage technical data and documentation to ensure timely action, compliant storage, and efficient retrieval.Organize quality agreements and audit schedules for service providers, monitor and improve their performance, and maintain a qualified service providers list.Maintain awareness of the contract research and manufacturing environment and relevant service offerings.Support the development, implementation, maintenance, and monitoring of quality systems for non-clinical safety studies and CMC activities to assure compliance with GLP, GMP and GDP requirements.He/she establishes and maintains effective working relationships with a range of external contract research organizations, contract manufacturing organizations, industrial partners, and expert consultants.Apply robust knowledge of non-clinical safety studies, CMC activities, regulatory requirements, and their relationship to the drug development process.As required, apply substantial experience of managing international business relationships with external project partners and service providers.