BARDA Product Process Development and Analyst 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.  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.Product Process Development and Analyst Subject Matter Expert Specific Responsibilities Apply expert ability to deliver work products related to the development and management of product manufacturing processes, product formulation, and product presentation and lot release product analysis and methods.Work as part of an interdisciplinary team to assist BARDA contractors to develop valid, high-yielding, and economical processes as well as analytical methods to produce biopharmaceutical products with an emphasis towards monoclonal antibodies.Coordinate with program managers, scientists, and other subject matter experts as required.Review the CMC aspects of biopharmaceutical product development plans/proposals for feasibility, assist in the rating and selection of projects against government needs, and assist in the post award monitoring of project execution against set plans and schedules.Review and advise on development of drug product formulations.Review and advise on the development and validation of analytical procedures, and development of specifications.Review and advise on the development of stability programs and analysis of stability data.Assess design and operation of manufacturing facilities for compliance with cGMP.Evaluate contractor’s risk management programs for product development processes and assist in their modification as needed.Monitor approach and performance of quality assurance and regulatory compliance for contracted projects.Perform site visits/audits with the government’s Contracting Officer (CO) at contractor’s facilities, and/or facilities of subcontractors.Monitoring compliance with contract requirements, federal regulations, and FDA and ICH CMC guidelines.Prepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and assist offerors in their development of proposed project SOW’s.