QC Analyst IV-Assay Validation 628881 (NCI)
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POST DATE 8/31/2016
END DATE 10/23/2016
Leidos Biomedical Research, Inc.
JOB DESCRIPTIONLeidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
For more information about Leidos Biomedical Research Inc., please visit our webpage at www.leidosbiomed.com.
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.
Reporting into the QC Assay Validation Scientist, this position will:
1) Facilitate the transfer of new methods from an external laboratory to Quality Control by preparing supporting documentation, performing complex data analysis, and coordinating laboratory activities
2) Draft and execute method qualification protocols and reports
3) Perform pre-qualification and qualification experiments on bioanalytical methods such as binding assays, HPLC, ELISA, Western blots, and gel electrophoresis
4) Provide on-going assessment of method performance for all qualified methods
5) Assist QC analysts with the analytical instrument qualification process,
6) Participate in method or equipment troubleshooting activities as needed,
7) Prepare technical presentations for meetings with internal and external customers
8) Interact regularly with QC analysts and management, in addition to the Government Client.