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The Vaccine Clinical Materials Program, SAIC-Frederick, Inc. supports the Vaccine Research Center in manufacturing materials for Phase I & Phase II clinical trials. In this role, you will be responsible for conducting routine and non-routine analysis of in-process samples and finished drug product according to Standard Operating Procedures (SOPs). Ensures compliance with SOPs and cGMP regulations. Follows good documentation practices to ensure appropriate documentation of test results. Performs required data analysis, compiles data, interprets data findings, investigates issues and reports abnormalities. Prepares and submits reports for review. Maintains lab equipment. Participates in out-of-specification investigations and recommends corrective actions. Revises and updates SOPs. Maintains the safety and orderliness of the lab. May work in a BL2 environment.
REQUIRED SKILLS: Requires a Bachelors degree from an accredited college/university in a scientific discipline or equivalent experience. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to the education experience, a minimum of 5 years related experience is required. Knowledge of current Good Manufacturing Practices (cGMPs), knowledge of laboratory environment and equipment used for biopharmaceutical analysis. Ability to perform a variety of analyses HPLC, capillary electrophoresis, gel electrophoresis, western blot, cell culture, spectrophotometric, and ligand binding assays. May be required to work flexible hours including weekends and evenings. This position is subject to obtaining a Public Trust Clearance.
DESIRED SKILLS: Strong analytical chemistry skills with emphasis on HPLC and capillary electrophoresis techniques. Experience with and/or knowledge of plasmid DNA analysis; adenoviral vector analysis. Knowledge of PCR testing for process residuals.
Consider joining the ranks of SAIC's 45,000 employees who are committed to success and innovation. For immediate consideration, please submit your resume online. ©2009 SAIC. All rights reserved. Equal Opportunity Employer.
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