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Scientific Program Manager

ORAU has a contingent job opportunity for a Scientific Program Manager in support of the overall functions of Vaccine Translational Research Branch in the Vaccine Research Program, Division of AIDS (DAIDS), located in Bethesda, MD. The position is contingent on award of an upcoming contract with NIAID Professional, Scientific and Technical Support Services. Salary for positions will be determined based on education and experience. Relocation support is not available for this position.
ORAU has been providing scientific and technical talent staffing solutions and designing, managing, and evaluating jobs and internships for more than 70 years. ORAU assists in connecting the best and most diverse group of students, recent graduates, faculty and professionals with world-class fellowships, internships and job opportunities, whether in national laboratories, research institutions, federal government offices or private sector R&D departments.
Technical Requirements:
  • Work with federal staff responsible for GMP product development of vaccines for infectious diseases including the production of investigational products that are identified as strong candidates to move from a preclinical to clinical phase.
  • Participate as a team member in a group composed of different staffing areas including scientific/technical roles, project management, regulatory affairs, quality assurance, contracts and finance. Activities include: participating in both the development of vaccines and adjuvants, assisting in the authoring the Chemistry, Manufacturing and Controls and Toxicology sections of Investigational New Drug submissions, providing protocol and Investigator Brochure review, and assisting in providing oversight of Contract Manufacturing Organizations.
  • Assist in the evaluation and propose appropriate toxicity studies and models for products intended to be studied as vaccines.
  • Coordinate with Quality, Regulatory and Technical team members for health regulatory compliance.
  • Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies.
  • Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies.
  • Prepare technical reports, updates and summaries for internal meetings with Division Management.
  • Perform site-visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC.
  • Review, GMP manufacturing batch records, SOPS, deviation reports, etc.
  • Participate with Team members to track product stability reports with respect to stability timepoints, review the product stability protocol for consistency and completeness, ensure that the stability program matches the requirement per the project Statement of Work, review stability Certificate of Analysis and/or Stability reports/data for out of specification testing results, issue the Shelf Life Extension document after reviewing of the stability report.
  • Assist in the preparation and review of regulatory documents including pre-IND materials, and IND, as required.
  • Prepare oral and written presentations for internal and external programmatic and scientific meetings.
  • Participate in on site audits of vendors.