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 the leading medical research center in the world. We are currently seeking a Scientific Program Manager with HIV Vaccine Regulatory expertise to work onsite with the National Institutes of Health in Rockville, MD.
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Vacation leave as well as 10 paid federal holidays and 401K plan
- Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS: The contractor shall:
- 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.
- Participate in 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.
REQUIREMENTS: The contractor must have:
- Minimum of Bachelor’s degree in Biology, Life Sciences or other related discipline.
- Experience in product development of vaccines for infectious diseases, specifically HIV.
- Experience with viral and/or bacterial vectors for specific use as HIV vaccines.
- GMP knowledge and regulatory submission expertise based on work with HIV vaccines or other related infectious diseases.
- Excellent written and oral communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Excellent analytical, organizational, and time management skills.
- Experience with Microsoft Office programs (Word, Excel, PowerPoint).
PLEASE APPLY ONLINE
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; a full job description can be made available at that time.
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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