FDA Product Aggregates and Immunogenicity Fellowship
*Applications will be reviewed on a rolling-basis.
An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in the Office of Pharmaceutical Quality (OPQ)/Office of Biotechnology Products in Silver Spring, Maryland.
The Office of Pharmaceutical Quality’s (OPQ) mission is to assure that quality medicines are available for the American public. OPQ integrates assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. OPQ supports “One Quality Voice,” creating a uniform drug quality program across all sites of manufacturing -- domestic or foreign -- and across all human drug product areas including new drugs and biologics, generics, biosimilars, and also over-the-counter drugs and compounded drug products. OPQ also encourages the adoption of emerging technologies to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector.
Uncertainty over the potential of product and process related impurities impact immunogenicity, which cannot be predicted by bioanalytical characterization of the active product ingredient (API), can hinder accelerated regulatory paths for some products. This project will explore optimization of methods capable of assessing whether unknown impurities in the product could increase the immunogenicity risk to: (1) improve sponsors' control of IIRMI, (2) improve risk assessments and reduce residual uncertainty, (3) facilitate review of complex products, and (4) assist in the determination of the extent of clinical trials needed to assess immunogenicity due to manufacturing changes.
Under the guidance of a mentor, the participant will be involved in training related to in vitro methods to assess the immunomodulatory activity of products, as well as developing and validating in vivo methods to assess the immunomodulatory activity of products in order to gain understanding of the immunogenicity risk associated with the presence of different types of aggregates and impurities in therapeutic products.
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 one year, 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 is full-time 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.
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. 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-2020-0535) in your email.