Today
Unspecified
Senior Level Career (10+ yrs experience)
Occasional travel
Healthcare and Science
Washington, DC (On/Off-Site)
Sr. Programmatic / Technical Advisor
Department of Health and Human Services, Administration for Strategic Preparedness and Response (ASPR), Center for Biomedical Advanced Research and Development Authority (BARDA)
BACKGROUND: ASPR/BARDA's overarching mission is to support R&D efforts aimed at delivering medical countermeasures for public health consequences of CBRN events, pandemic influenza, and emerging infectious diseases. BARDA was formally established under the Pandemic and All-Hazards Preparedness Act (PAHPA; PL 109-417), signed into law on December 19, 2006. Title IV of PAHPA specifically mandated BARDA's role within HHS to coordinate the accelerated advanced research and development of medical countermeasures. This coordination involves collaboration with medical countermeasure developers and manufacturers, direct support for advanced R&D, facilitation of advice from regulatory bodies like the HHS Food and Drug Administration (FDA) and fostering innovation in technologies and strategic initiatives. BARDA employs a comprehensive portfolio approach to develop and acquire a wide array of MCMs, including vaccines, therapeutics, diagnostics, and non-pharmaceutical products. This strategy involves coordinating and co-managing MCM programs across various HHS agencies and other United States Government (USG) agencies, as well as engaging with industry stakeholders through public-private partnerships. The pandemic influenza program, for example, is instrumental in establishing national networks and centers to sustain domestic manufacturing infrastructure for these MCMs. Recognizing the global nature of pandemics, BARDA also supports USG global leadership and obligations by assisting in building influenza vaccine manufacturing capacity in developing countries through direct funding and technical expertise. Within the CBRN program, BARDA manages extramural initiatives that support advanced R&D and stockpiling acquisition of CBRN MCMs under Project BioShield. This portfolio includes candidates and products targeting smallpox, hemorrhagic fever viruses, anthrax, botulism, plague, tularemia, radiological and nuclear agents, nerve agents, and other bio-threats.
Place of Performance: Washington, DC. Onsite: Constitution Center
Period of Performance: 12-month base period, plus (4) four 12-month option periods. Anticipated start date of 2/27/26.
Requirements:
• Candidates must demonstrate experience in: the understanding of medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Minimum of Twelve (12) years of relevant experience with a doctoral degree in biological and/or chemical sciences with relevant postdoctoral experience
• OR clinical studies: application of doctoral degree(s) in medicine or pharmacy or with commensurate experience(s) advanced degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including seven (7) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software.
• Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred. PhD in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Masters or Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)
• OR relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions, application of degree in biology, chemistry, or pharmacy with commensurate experience.
• OR a bachelor's degree in chemistry, Engineering or Biology including ten (10) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
Duties and responsibilities will include, but are not limited to, the following:
• Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.
• Provide advance services including but not limited to: Data cleaning Data transfers Data quality control Data integration and validation Data analysis and report package preparation Statistical simulation Statistical toolbox for advanced data modelling, tabulation, and visualization In addition, this position will provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians.
• Directs tasks and leads technical efforts and scientific projects. Acts as an SME on scientific subjects. Contributes subject matter expertise to programs with technical or program management expertise. Facilitates meetings as directed.
• Provide advisory support to BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate on Program Coordination Teams (PCTs)
• Provide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed Participate in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Analyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed.
• Additional duties related to programmatic support for MCM maybe assigned.
Department of Health and Human Services, Administration for Strategic Preparedness and Response (ASPR), Center for Biomedical Advanced Research and Development Authority (BARDA)
BACKGROUND: ASPR/BARDA's overarching mission is to support R&D efforts aimed at delivering medical countermeasures for public health consequences of CBRN events, pandemic influenza, and emerging infectious diseases. BARDA was formally established under the Pandemic and All-Hazards Preparedness Act (PAHPA; PL 109-417), signed into law on December 19, 2006. Title IV of PAHPA specifically mandated BARDA's role within HHS to coordinate the accelerated advanced research and development of medical countermeasures. This coordination involves collaboration with medical countermeasure developers and manufacturers, direct support for advanced R&D, facilitation of advice from regulatory bodies like the HHS Food and Drug Administration (FDA) and fostering innovation in technologies and strategic initiatives. BARDA employs a comprehensive portfolio approach to develop and acquire a wide array of MCMs, including vaccines, therapeutics, diagnostics, and non-pharmaceutical products. This strategy involves coordinating and co-managing MCM programs across various HHS agencies and other United States Government (USG) agencies, as well as engaging with industry stakeholders through public-private partnerships. The pandemic influenza program, for example, is instrumental in establishing national networks and centers to sustain domestic manufacturing infrastructure for these MCMs. Recognizing the global nature of pandemics, BARDA also supports USG global leadership and obligations by assisting in building influenza vaccine manufacturing capacity in developing countries through direct funding and technical expertise. Within the CBRN program, BARDA manages extramural initiatives that support advanced R&D and stockpiling acquisition of CBRN MCMs under Project BioShield. This portfolio includes candidates and products targeting smallpox, hemorrhagic fever viruses, anthrax, botulism, plague, tularemia, radiological and nuclear agents, nerve agents, and other bio-threats.
Place of Performance: Washington, DC. Onsite: Constitution Center
Period of Performance: 12-month base period, plus (4) four 12-month option periods. Anticipated start date of 2/27/26.
Requirements:
• Candidates must demonstrate experience in: the understanding of medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• Minimum of Twelve (12) years of relevant experience with a doctoral degree in biological and/or chemical sciences with relevant postdoctoral experience
• OR clinical studies: application of doctoral degree(s) in medicine or pharmacy or with commensurate experience(s) advanced degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including seven (7) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software.
• Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred. PhD in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Masters or Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)
• OR relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions, application of degree in biology, chemistry, or pharmacy with commensurate experience.
• OR a bachelor's degree in chemistry, Engineering or Biology including ten (10) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
Duties and responsibilities will include, but are not limited to, the following:
• Provide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.
• Provide advance services including but not limited to: Data cleaning Data transfers Data quality control Data integration and validation Data analysis and report package preparation Statistical simulation Statistical toolbox for advanced data modelling, tabulation, and visualization In addition, this position will provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians.
• Directs tasks and leads technical efforts and scientific projects. Acts as an SME on scientific subjects. Contributes subject matter expertise to programs with technical or program management expertise. Facilitates meetings as directed.
• Provide advisory support to BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate on Program Coordination Teams (PCTs)
• Provide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed Participate in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Analyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed.
• Additional duties related to programmatic support for MCM maybe assigned.
group id: 10439009
