BARDA Senior Manufacturing Program Manager

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.  Program Manager Responsibilities - General. Provide concept ideas for BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].Review and advise on contract proposals (formally and informally submitted), as requested.Provide project development level portfolio management and oversight.Provide program level portfolio management and oversight.Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.Assist in contract negotiations on technical matters, as requested.Senior Manufacturing PM Specific ResponsibilitiesSupervisor for multiple Manufacturing Program Managers.Supervisor for multiple Scale-Up Manufacturing Analysts.Supervisor for Drug/Vaccine Supply Chain Managers.Coordinate with program managers, scientists, and other subject matter experts as required.Primary point of contact for BARDA senior and executive leadership on manufacturing matters.Develop and execute long-term strategic plans to achieve organizational goals, including developing a strategic plan for the entire department or team.Establishing standards for performance and measuring progress towards goals, then communicating results to stakeholdersManaging complex, multi-faceted projects that require extensive planning, coordination, and communication with multiple departments within an organization.Determining how best to allocate resources across multiple projects or initiatives based on available funding and personnel.Analyzing data to identify problems and propose solutions.Develop and implement processes and procedures to ensure efficiency and consistency in operations.Provide SME in biopharmaceutical processes, manufacturing infrastructure development, manufacturing technology trends, and biomedical emergency preparedness & response.Provide program/project management & executive decision support for related projects.Assist new acquisitions, development of medical countermeasure (MCM) and related manufacturing infrastructure, optimization of MCM stockpiles, surveys & gap analyses, biomedical emergency response and ramp-down logistics, budget planning, development, and application of program/project management tools.Provide SME in the design, engineering, construction, and validation of biopharmaceutical manufacturing facilities.