Softtek Government Solutions · 3 months ago
Senior Programmatic Technical Advisor_BARDA
United States
Full-time
Remote
Senior Level, Lead/Staff
12+ years expAveshka Inc is looking for a Senior Programmatic Technical Advisor to support an HHS program with BARDA in Washington, DC. The role involves providing expertise and advisory support related to medical countermeasures for federal public health emergency responses, leading technical efforts, and participating in program coordination and strategic discussions.
Information Technology & Services
No H1B
U.S. Citizen Only
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. 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
Qualification
Required
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 twelve (12) years of relevant industry 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
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
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
Ability to obtain and maintain a NACI Background Check
Preferred
Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred
Company
Softtek Government Solutions
Softtek Government Solutions, formerly Aveshka, a Softtek Company, supports U.S.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Marcos J.
Chief Executive Officer
Dan Begg, PHR
Senior HR Business Partner
Recent News
2022-03-11
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