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Postbac Training - Development of New Investigational Biopharmaceutical Products

National Cancer Institute, Frederick, Maryland

Position Description:

The Biological Resources Branch (BRB) provides oversight of the Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) Advanced Technologies and Research Facility (ATRF) in Frederick, MD. The BDP develops a variety of biopharmaceuticals and produces them under current Good Manufacturing Practices (cGMP) for Phase I/II human clinical trials or advanced preclinical animal testing, including monoclonal antibodies, recombinant proteins and virus-like particles, viral and DNA vaccines, peptides, gene therapy products, and cell-based products such as engineered T cells. This position will provide training in development of new investigational biopharmaceutical products under FDA regulatory guidelines and will support one of the following activities:

  • Cell Therapy Product Manufacturing – Assists in the development of clinical cell therapy products under current Good Manufacturing Practices (cGMP); assists with the development of procedures to perform cGMP virus production and purification, assists in the set up and commissioning of new cell therapy cGMP production suites
  • Process Analytics / QC Testing – Assists in the execution of assays to determine critical quality attributes of biopharmaceutical products; reviews test results according to assay performance criteria and product specifications; assists in the development of such assays and the writing of Standard Operating Procedures (SOPs)
  • Quality Assurance / Regulatory Affairs – Assists with review of manufacturing and testing documentation for accuracy, completeness, and conformance to specifications; assists in regulatory compliance audits of manufacturing, QC, and other related activities; generates documents for submission to the FDA in support of Investigational New Drug (IND) applications
    In their cover letter, applicants shall provide their #1 and #2 preferences for the biopharmaceutical development activities described above.

Qualifications:

The Postbac IRTA/CRTA Program is for individuals who meet ONE of the following criteria:

  • college graduates who received their bachelor's degrees less than THREE years prior to the date they begin the program (regardless of whether they subsequently completed a master's degree), OR
  • individuals who are more than 3 years past the receipt of their bachelor's degree but received a master's degree less than SIX MONTHS before they begin the program OR
  • individuals who meet criterion (1) and/or (2) who have been accepted into graduate, other doctoral, or medical school programs and who have written permission from their school to delay entrance for up to one year to pursue a biomedical research project at the NIH.
  • To be eligible, candidates must also be U.S. citizens or permanent residents. In addition, they should intend to apply to graduate or professional school during their tenure at the NIH (if they have not already been accepted).

To Apply:

The application requires submission of

  • A curriculum vitae or resume,
  • A list of coursework and grades,
  • A cover letter describing the applicant's research interests and career goals, including their #1 and #2 preferences for the biopharmaceutical development activities described in the Position Description
  • The names and contact information for three references

Please send your applications to Jason Yovandich
yovandij@mail.nih.gov

The NIH is dedicated to building a diverse community in its training and employment programs and encourages the application and nomination of qualified women, minorities, and individuals with disabilities.