A research opportunity is available in the Office of Pharmaceutical Quality/Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
This research project involves investigation of emerging technologies in the manufacture of a therapeutic protein drug product. Our laboratory uses a laboratory-scale manufacturing process for the production and purification of model protein drug products. Potential projects include integration of a continuous downstream purification process or assessment of rapid microbial methods for adventitious agent detection.
- Knowledge in analytical chemistry involving biologic/protein drug molecules, including High Performance Liquid Chromatography, Capillary Electrophoresis (or micro-capillary), or other particle sizing techniques
- Knowledge in DNA extractions/PCR, microbial enumeration/bioburden testing, or viral preparations, aseptic technique