Mid_Programmatic_Technical Advisor

Aveshka • Vienna, VA

75d

About The Position

Softtek 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. 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.

Requirements

• 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.
• Minimum of eight (8) years of relevant industry experience.
• Graduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience.
• Clinical 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).
• Relevant industry experience 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.
• Bachelor'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.
• Ability to obtain and maintain a NACI Background Check.

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 a Subject Matter Expert (SME) on scientific subjects.
• Contribute subject matter expertise to programs with technical or program management expertise.
• Facilitate meetings as directed.
• Provide advisory support to BARDA Program Division(s).
• Prepare draft work statements (SOW, SOO, PWS IGCE & Cost Estimates) for solicitations.
• Serve as advisor on Technical Evaluation Panels (TEPs) including 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 may be assigned.

What This Job Offers

• Career Level: Mid Level
• Industry: Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services