Chief, Vaccine Production Program, Vaccine Research Center

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Job Summary

The Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is the primary intramural center for product development-oriented research efforts to rapidly develop and translate biomedical research into new vaccines and therapeutic products. VRC is seeking a chief for its Vaccine Production Program (VPP). The VPP is a unique component of the intramural research program at NIH, serving as the only federally managed cGMP facility in the United States capable of providing clinical material for both early and advanced phases of clinical investigation. The VPP translates materials from the bench into products for proof-of-concept clinical trials and enables rapid development for human trials and commercial licensure by partners. The chief, VPP, position is a senior member of the VRC’s leadership team and is directly responsible for the oversight and management of these translational research and product development processes, advancing benchtop discoveries to investigational biomedical products, which includes design, development, manufacturing, and evaluation of novel vaccines, adjuvants, monoclonal antibodies, bispecific antibodies, and multispecific antibodies. As part of these responsibilities, the chief, VPP, directs, leads, and controls all activities and output of a government funded and led, contractor leased and operated cGMP production facility, including allocation and monitoring of operational funds and contract management and oversight.

The chief, VPP, is specifically responsible for the following:

  1. Demonstrating a high level of understanding of all facets of the NIAID/VRC research portfolio (basic, applied, and clinical research) as well as animal model research and preclinical toxicology necessary to develop and advance novel vaccines and monoclonal antibodies
  2. Providing the VRC director and NIAID leadership with highly complex recommendations regarding timelines for producing clinical products, inclusive of strengths and weaknesses for proposed product platforms and recommending selection and prioritization of proposed clinical products
  3. Leading and managing the full range of vaccine and product development activities, to include upstream and downstream processes necessary for the development and validation of manufacturing processes, formulation sciences to ensure stability of clinical products, analytical development to evaluate the biological/clinical materials, and scientific operations and data management, site operations, and services
  4. Ensuring that all aspects of research and development processes meet with the highest regulatory science standards
  5. Managing and prioritizing the VPP scientific portfolio to maximize NIH/NIAID return on intramural research investment to meet critical public health and national biodefense needs and serving as a national expert on vaccine platform and manufacturing technology research
  6. Fostering high-profile and high-value collaborations with external partners to advance VRC products into human clinical trials. Collaborators include investigators from public and private sector entities, e.g., pharmaceutical sector; academic centers; the United States Department of Defense, including Walter Reed Army Institute of Research (WRAIR), Defense Advanced Research Projects Agency (DARPA), and United States Military HIV Research Program (MHRP); the HHS Office of the Assistant Secretary for Preparedness and Response (ASRP); and the Biomedical Advanced Research and Development Authority (BARDA). These collaborations are essential to achieving the NIH’s fundamental mission of turning discovery into health.

Required Qualifications

To be eligible for this position, candidates must be a U.S. citizen, or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. Candidates must indicate their U.S. citizenship status on their CV or within their email application submission.

In order to qualify for this position, candidates must possess either a doctoral-level degree in biomedicine or a biological related field, or a master's level or higher degree in:

  • engineering
  • bioinformatics
  • or an emerging or related scientific field.

In addition, candidates must have at least one year of experience related to the position, including achievements in one or more of the following areas to demonstrate the individual has received recognition as an expert in the field:

  • Has significant experience dealing with complex, precedent-setting evaluation, scientific policies or development issues (e.g., those associated with novel biomedical products, novel approaches to biomedical product manufacturing, or use of novel evaluation methods)
  • Demonstrated cutting-edge expertise in a scientific or technical discipline critical to design, development, manufacturing, clinical performance assessment, or technical aspects of effective oversight of biomedical products
  • Played a leadership role in planning and conducting public meetings to seek public input and communicate regulatory scientific policies
  • Received invitations to speak at or chair major national or international meetings and symposia or
  • Meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related activity or field that is necessary to the accomplishment of NIH's mission.

If you are a current Federal Title 5 employee, you must have one year of equivalent experience at the GS-14 level or above.

Benefits

A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits.

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Equal Employment Opportunity

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants.

Standards of Conduct/Financial Disclosure

If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency.

Foreign Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Learn more about Foreign Education.

Reasonable Accommodation

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

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