FDA Drug Quality Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality / Office of Testing and Research, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in St. Louis, Missouri.
The massive increase in cost of H.P. Acthar gel has become a public health burden and a barrier for its accessibility to the patients in need, particularly the pediatric population. From a public health point of view, investing in research to analyze the critical quality attributes of Acthar gel drug products helps to establish a scientifically appropriate pathway for approving a generic/505(b)(2) Acthar product. Currently, there are no analytical methods developed that specifically characterize and quantifies the Acthar Gel peptide content.
Under the guidance of a mentor, the participant will receive training and be able to perform laboratory research related to the development and validation of methods for the characterization and quantification of peptide therapeutics, sequencing and determination of impurities in drug substances and drug products by using mass spectrometry (MS)-based techniques.
Qualifications
The qualified candidate should have received a doctoral degree in one of the relevant fields, preferably fields related to pharmaceutical sciences or medicinal chemistry, or be currently pursuing the degree and will reach completion by May 2020. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0524) in your email.