BARDA : Drug/Vaccine/ Diagnostic/Clinical Development SME

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. Subject Matter Expert Responsibilities – General.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) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.Provide guidance and recommendations on key issues related to the area(s) identified above.Review study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Provide senior-level briefing(s) to ASPR/BARDA as required.Prepare regular reports to ASPR/BARDA management on various technical issues identified as required.Provide recommendations for project development level portfolio management and oversight as required.Develop, 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.