BARDA Senior 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.Senior Product Process Development and Analyst Subject Matter Expert Specific Responsibilities. Work as part of an interdisciplinary team to assist BARDA contractors to develop valid, high-yielding, and economical processes as well as analytical methods for the production of biopharmaceutical products with an emphasis towards monoclonal antibodies.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.Coordinate with program managers, scientists, and other subject matter experts as required.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 guidelinesPrepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP) and assist offerors in their development of proposed project SOW’s.Desired ExpertiseMid and late-stage monoclonal antibody and other biopharmaceutical product development, process validation and manufacturing including the following areas:Cell culture or fermentation process development and scale-up manufacturing.Development of purification unit operations such as chromatography, centrifugation, microfiltration, ultrafiltration and/or extraction.Familiarity with analytical test development for evaluation of product characteristics such as concentration, potency or activity evaluation of in-process, drug substance and drug product samples.Thorough understanding of the principles of QbD and process design space development and validationProcess characterization and evaluation of new technologies.Aseptic vial/syringe/other fill and finish validation and manufacturing operations for biopharmaceutical liquid and/or lyophilized formulations.Experience in manufacturing technology transfer between development and manufacturing operations and/or between facilities or external partners/collaborators.Proven written and verbal collaboration skills with a demonstrated ability to interact and provide influential technical recommendations.