Overview Leidos is seeking Scientific Technical Advisors, contingent upon contract award, to be performed hybrid onsite in Washington, DC. Responsibilities 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. Provide ad hoc statistical support to BARDA projects under the guidance of BARDA statisticians. Direct tasks and lead technical efforts and scientific projects. Act as an SME on scientific subjects. Contribute subject matter expertise to programs with technical or program management expertise. Provide advisory support to BARDA Program Division(s); prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations (RFIs, RFPs, SSNs, etc.). 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 aligned with BARDA's mission space. Provide recommendations for project development level portfolio management and oversight as required. Provide recommendations or advise on development, implementation, and conscious improvement of 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 may be assigned. Qualifications 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 technique, sterile manufacturing/filling and sterile facilities (sterile gowning). Provide guidance and recommendations on key issues related to the area(s) identified above. Minimum Requirements: Bachelor's degree (graduate preferred) in an appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Bachelor's in a physical science field (engineering, physics, computer science, or similar) with commensurate experience, or relevant industry experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control positions, with application of degree in biology, chemistry, or pharmacy with commensurate experience. Or a bachelor's degree in chemistry, engineering or biology including five (5) 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; or equivalent. Programmatic / Technical Advisor Qualifications: Minimum of five (5) years of relevant industry experience with a bachelor's degree; graduate (preferred) in biological and/or chemical sciences with relevant experience or post-graduate degree(s) in medicine or pharmacy, or with commensurate experience; a bachelor's degree in computer science, statistics, or related fields accessible. Extensive knowledge and experience in clinical trials and epidemiological research including three (3) 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. A waiver may be issued by the government if the candidate has a combination of years of industry experience and/or degree in the desired discipline along with a minimum of one year (52 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM). PHHS Come break things (in a good way). Then build them smarter. We're the tech company everyone calls when things get weird. We don't wear capes (they're a safety hazard), but we do solve high-stakes problems with code, caffeine, and a healthy disregard for "how it's always been done." For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above. Pay Range: $85,150.00 - $153,925.00

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