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1+ months

Scientific Program Manager (HIV Vaccine Regulatory experience) - NIH - Rockville

Kelly Services
Rockville, MD 20851
Kelly Government 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 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 HIV Vaccine Regulatory experience to work onsite with the National Institutes of Health in Rockville, MD.





This is a long-term contract position which offers:



- Competitive salary with comprehensive benefit package



- Opportunity to work at NIH, the world's foremost medical research center



- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com





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 pre-clinical 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 Bachelors 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



Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.




**Why Kelly** **** **?**



Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.




**About Kelly** ****



Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law.

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Posted: 2020-08-21 Expires: 2020-10-22

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Scientific Program Manager (HIV Vaccine Regulatory experience) - NIH - Rockville

Kelly Services
Rockville, MD 20851

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