BARDA Small Molecule Drug 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.  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.Small Molecule Drug Development Subject Matter Expert Specific Responsibilities. Independently review and document preclinical formulation (PK-PD, Tox, and others for various routes of administration) for small molecule drug candidates.Perform thorough active pharmaceutical ingredient (API) characterization, stability, and compatibility studies.Assist in critical activities in the pre-formulation and formulation area and represent group in multidisciplinary project teams responsible for advancing preclinical and clinical pipeline.Provide support, as needed, to clinical drug product development and manufacturing through material assessment, stability, and compatibility studies.Author guideline technical protocols, reports, scientific papers, patent, and relevant regulatory sections in IND, IMPD, NDA, and other filings.Possess a broad understanding of API characterization and preclinical formulation development.Apply familiarity working with complex laboratory operations and instrumentation including U/HPLC, PXRD, DSC, TGA, Raman, IR, SEM, PLM, etc.Apply knowledge of small molecule API assessment, preclinical formulation development, and concepts involved in process.Use hands-on experience with operations involved in preclinical formulation development.Possess strong skills and understanding of various thermal characterization techniques and abilities to effectively utilize them in solving problems.