Kelly Services
Location
Rockville, MD | United States
Job description
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Scientific Program Manager with the National Institutes of Health in Bethesda, Maryland.
Scope:
Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the Vaccine Translational Research Branch, Vaccine Research Program, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID).
Specific Qualifications:
PMP certification and experience in managing cGMP of biologics is preferred.
M.S. degree in biochemistry or biology or equivalent education and at least 8 years of experience in industry, or B.S. degree in biochemistry or biology or equivalent education and at least 10 years of experience in industry
Tasks:
• Work with federal staff responsible for cGMP 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.
• Plan, organize, and coordinate cGMP activities across all project stakeholders. Set deadlines, record responsibilities, and monitor and summarize progress of various cGMP manufacturing projects.
• 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
• Coordinate with Quality, Regulatory, and Technical team members for health regulatory compliance.
• Assist the team with impact/risk assessment from issues, failures, and deviations during manufacturing and pre-clinical studies.
• Develop, coordinate, and monitor business agreements to include MTAs, CRADAs, DTAs, and other agreements as necessary.
• Prepare technical reports, updates, and summaries for internal meetings with Division Management.
• Map out VTRB process and support the development of Standard Operating Procedures (SOPs) and advise the VTRB Branch Chief if the processes are appropriate to adhere to the cGMP requirements. Stay current on training and understanding approved SOPs. Assist in tracking and periodic review of VTRB SOPs
• Maintain an organized, efficient, and accessible electronic document filing system. This includes historical, current, and projected information on proposals, presentations, business agreements, grant awards, cGMP projects, and other Branch activities.
• 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.
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position.
Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.
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