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Development Associate III (Downstream) 160315 (NCI)

Smart People Solving Hard Problems. The world's critical and intriguing problems demand solutions that are startlingly different. Where is this type of challenge and thinking to be found? At SAIC, the FORTUNE 500® scientific, engineering, and technology applications company that is working to solve problems of vital importance to the nation and the world.


THIS POSITION IS CONTINGENT UPON AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDING.

The Vaccine Clinical Materials Program, SAIC-Frederick, Inc. supports the Vaccine Research Center in manufacturing materials for Phase I & Phase II clinical trials. Will assist in developing scalable processes with improved product yield and reduced costs for manufacturing systems. Additionally, assist with maintenance of production equipment. May research and implement new methods and technologies to enhance operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments. Identification and optimization of purification procedures in advance of GMP manufacturing Performs basic analytical methods and/or coordinates analytical activities with QC/AD. Development of processes consistent with the regulatory and GMP compliance requirements and all requirements specified by VCMP operational procedures. Evaluation of new technologies or new applications of established technologies that lead to improved product quality and lower costs by improving production yield; research and implement new technologies for the production and/or analysis of products in development. Assists with technology transfer of processes to the Manufacturing group. May write SOPs and Batch Production Records without oversight. May participate in the review of completed Batch Production Records.

REQUIRED SKILLS: This position 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 along with a demonstrated working knowledge of scientific principles. Ability to follow Standard Operating Procedures as well as verbal and written instructions; set up, operate and maintain laboratory and analytical equipment; Formulate buffers and other reagents used in laboratory experiments; maintain an accurate written record of experimental procedures and results. Ability to interact effectively with other groups within the VCMP; write/review technical documents, SOPs and Batch Production Records; design, execute and interpret experimental data. Knowledge of Biochemistry of protein, nucleic acids and/or viruses; working knowledge of computer operated equipment pertaining to the development of biopharmaceuticals. Ability to lift up to 35 pounds and work in a BL2 environment. May be required to work flexible hours including weekends and evenings. This position is subject to obtaining a Public Trust Clearance.

DESIRED SKILLS: Current understanding of Good Manufacturing Practices.


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