FDA Glycoprotein Production and Characterization Fellowship
*Applications will be reviewed on a rolling-basis.
Two research opportunities are currently available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality/ Office of Biotechnology Products (OBP) located in Silver Spring, Maryland.
This research project leverages state-of-the-art instrumentation for laboratory-scale protein production, purification, and physiochemical and biological characterization studies to identify potential critical quality attributes that can impact drug product safety and quality. Using high-throughput mammalian colony screening technology, high producing clonally-derived cell lines are screened, identified and cultivated for protein production. Using sequential single- and multi-column chromatographic separation methods, the protein purification process is optimized in a manner that is comparable to commercial downstream processes to advance risk evaluations. The purified experimental proteins are subjected to semi-automated analytical technologies that can characterize several critical quality attributes, such as identity, purity, isoelectric point, glycosylation, and, biological activity antibodies.
Under the guidance of a mentor, the participant may be involved in the following activities:
- Developing and characterizing new cell-based platform technology and cell lines that produce novel experimental therapeutic proteins using high-throughput technology to improve the manufacture of safe and effective commercial therapeutic proteins with high quality.
- Producing and purifying novel proteins using laboratory-scaled methods that are based on commercial upstream and downstream manufacturing process for large molecule drug products.
- Characterizing the biochemical and physiochemical properties of experimental therapeutic proteins to identify potential critical quality attributes that affect the safety, quality, and efficacy of commercial therapeutic proteins, such as identity, purity, potency, strength, and glycosylation.
- Training and exploration of new cell development methods and bioprocessing/analytical instrumentation including: mammalian colony picking equipment, plate- and tube- based flow cytometry, biolayer interferometry, High performance liquid chromatography, mass spectrometry (Q and QQQ), flow-imaging, and UV-Vis spectrometry .
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for eleven months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment can be full-time or part-time, based on the participant's availability, at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.