Programmatic Technical Advisor

About the Role:

Culmen International is looking for a Programmatic Technical Advisor to support a HHS program in Washington, DC.

This work will support the Critical Operations, Research & Expertise (CORE), Scientific and Programmatic Assistance Services and are important in helping BARDA in developing medical solutions in biotechnology and biopharmaceuticals. These services help BARDA respond to public health threats from chemicals, germs, radiation, nuclear events, pandemic flu, and new infectious diseases. BARDA works closely with developers, manufacturers, and government agencies like the FDA to move research forward, encourage new ideas, and coordinate with HHS, other government groups, and industry partners. BARDA's work includes vaccines, treatments, tests, and products that are not medicines. The pandemic flu program increases vaccine production in the US and worldwide, particularly in developing countries. The CBRN division works with NIH, CDC, and industry to improve animal testing, product recipes, and lab testing. The Emerging Infectious Diseases program is also setting up ways to review and add new or returning diseases to BARDA's work, including those that need EPA approval.

What You'll Do in Your New Role:

• 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

Required Qualifications:

• Bachelor' s degree Graduate (preferred) in biological and/or chemical sciences with relevant experience
• 5+ years of relevant industry experience

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 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.
• Must be able to obtain and maintain NACI Background Check.

About the Company:

Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.

• Exceptional Medical/Dental/Vision coverage with 100% of the premiums paid by the company for all eligible employees and their eligible dependents (including same or opposite sex domestic partners)
• 401k – Vested immediately and 4% match
• Life insurance and disability paid by the company
• AFLAC Available
• Opportunities for Training and Continuing Education
• 12 Paid Holidays

To learn more about Culmen International, please visit

At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.