Senior Scientific Technical Advisors

Leidos is seeking Senior Scientific Technical Advisors, contingent upon contract award, to be performed hybrid onsite in Washington, DC.

Candidate MUST:

Be a US Citizen or Green Card Holder with the ability to obtain a Public Trust Clearance

Be located w/in 50 miles of location for hybrid/onsite work.

Duties:

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.

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.

Senior Programmatic / Technical Advisor Qualifications:

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. *Or equivalent*

Minimum of Twelve (12) years of relevant experience with 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.

Waiver maybe issued by the government if the proposed candidate has a combination minimum of