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This position is located in the Office of Therapeutic Proteins, Office of Biotechnology Products (OBP), Office of Pharmaceutical Science (OPS) at the Center for Drug Evaluation and Research (CDER). You will serve as a Staff Scientist performing research and regulatory review activities.
This job opportunity announcement may be used to fill additional vacancies.
- Conducts experimental studies that are consistent with the mission/goals of the Division, Office, Center, and Agency.
- Performs research on TLR9 agonists and their use as immune response modulators in humans, rhesus macaques and mice.
- Explores the biomarkers of innate immune activation form specific cell types such as pDC in vitro.
- Reviews Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), related amendments and supplements for regulatory compliance.
- Prepares scientific and regulatory manuscripts and reports for internal and external audiences.
- Serves as a reviewer for preparing grants, research manuscripts and other scientific exchanges.Presents results of research studies at internal and external meetings.