{"schemaVersion":"jobsearcher.job.v1","id":"8a3626abbbe4cb08048d7c78","url":"https://jobsearcher.com/jobs/8a3626abbbe4cb08048d7c78","canonicalUrl":"https://jobsearcher.com/jobs/8a3626abbbe4cb08048d7c78","title":"Mid_Programmatic_Technical Advisor","description":"Mid-Level Programmatic/Technical Advisor – HHS ASPR BARDA\nBackground:\nSofttek Government Solutions is looking for a Mid-Level Programmatic/Technical Advisor to support an HHS program – Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services – with ASPR/BARDA in Washington, DC.\nPersonnel on the Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services contract will support BARDA in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals. These services are critical in support of BARDA’s mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.\nDuties/Responsibilities:\nProvide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.\nProvide advance services including but not limited to:\nData cleaning\nData transfers\nData quality control\nData integration and validation\nData analysis and report package preparation\nStatistical simulation\nStatistical 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.\nDirects 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.\nProvide 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].\nServe as advisor on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.\nParticipate on Program Coordination Teams (PCTs)\nProvide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed\nParticipate in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.\nProvide recommendations for project development level portfolio management and oversight as required.\nProvide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.\nAnalyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed.\nAdditional duties related to programmatic support for MCM maybe assigned.\nRequired Qualifications and Experience\nUnderstanding 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.\nExperience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning). Plastic consumable design and manufacturing.\nProvide guidance and recommendations on key issues related to the area(s) identified above.\nMinimum of eight (8) years of relevant industry experience with:\nGraduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience. OR\nClinical studies: application of an advanced degree(s) in medicine or pharmacy or with commensurate experience(s) master's degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including five (5) 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. Advanced degree in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or master’s (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar). OR\nRelevant 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\nBachelor's degree in chemistry, Engineering or Biology including eight (8) 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.\nAbility to obtain and maintain a NACI Background Check.","company":"Softtek Government Solutions","rawCompany":"softtek government solutions","city":"Oakton","state":"VA","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:21:19.168Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"13-1082.00","title":"Project Management Specialists","slug":"project-management-specialists"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Mid_Programmatic_Technical Advisor","description":"Mid-Level Programmatic/Technical Advisor – HHS ASPR BARDA\nBackground:\nSofttek Government Solutions is looking for a Mid-Level Programmatic/Technical Advisor to support an HHS program – Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services – with ASPR/BARDA in Washington, DC.\nPersonnel on the Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services contract will support BARDA in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals. These services are critical in support of BARDA’s mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.\nDuties/Responsibilities:\nProvide expertise and advisory support related to medical countermeasures being utilized for federal public health emergency responses.\nProvide advance services including but not limited to:\nData cleaning\nData transfers\nData quality control\nData integration and validation\nData analysis and report package preparation\nStatistical simulation\nStatistical 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.\nDirects 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.\nProvide 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].\nServe as advisor on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.\nParticipate on Program Coordination Teams (PCTs)\nProvide assessments, recommendations, and guidance as well as educational material to PCT and COR, as needed\nParticipate in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.\nProvide recommendations for project development level portfolio management and oversight as required.\nProvide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.\nAnalyze protocols, study reports, regulatory documents, presentations, proposals, and related documents, as needed.\nAdditional duties related to programmatic support for MCM maybe assigned.\nRequired Qualifications and Experience\nUnderstanding 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.\nExperience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning). Plastic consumable design and manufacturing.\nProvide guidance and recommendations on key issues related to the area(s) identified above.\nMinimum of eight (8) years of relevant industry experience with:\nGraduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience. OR\nClinical studies: application of an advanced degree(s) in medicine or pharmacy or with commensurate experience(s) master's degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including five (5) 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. Advanced degree in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or master’s (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar). OR\nRelevant 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\nBachelor's degree in chemistry, Engineering or Biology including eight (8) 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.\nAbility to obtain and maintain a NACI Background Check.","datePosted":"2026-04-14T10:21:19.168Z","dateModified":"2026-04-14T10:21:19.168Z","hiringOrganization":{"@type":"Organization","name":"Softtek Government Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Oakton","addressRegion":"VA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8a3626abbbe4cb08048d7c78"},"url":"https://jobsearcher.com/jobs/8a3626abbbe4cb08048d7c78"}}