Program _Technical Advisor_HHS ASPR BARDA

Required Qualifications and Experience 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. Post graduate degree(s) in medicine or pharmacy or with commensurate experience(s) bachelor's degree in computer science, Statistics, or related fields 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.

Program/Technical Advisor - HHS ASPR BARDA

Background:

Softtek Government Solutions is looking for a Program/Technical Advisor to support an HHS program - Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services - with ASPR/BARDA in Washington, DC.

Personnel 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.

Duties/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:
  1. Data cleaning
  2. Data transfers
  3. Data quality control
  4. Data integration and validation
  5. Data analysis and report package preparation
  6. Statistical simulation
  7. 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 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.

Required Qualifications and Experience

• 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.
• Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning). Plastic consumable design and manufacturing.
• Provide guidance and recommendations on key issues related to the area(s) identified above.
• Minimum of Five (5) years of relevant industry experience with:
• Bachelor' s degree Graduate (preferred) in biological and/or chemical sciences with relevant experience post graduate degree(s) in medicine or pharmacy or with commensurate experience(s) bachelor's degree in computer science, Statistics, or related fields OR
• Post graduate degree(s) in medicine or pharmacy or with commensurate experience(s) bachelor's degree in computer science, Statistics, or related fields 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. Bachelor's degree (graduate preferred) appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), 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
• 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.
• Ability to obtain and maintain a NACI Background Check.