Assay Development Associate
GLC Healthcare - Bethesda, MD

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GLC Government Services is seeking an Assay Development Associate for a full time contract assignment at the National Institutes of Allergy and Infectious Disease located in Bethesda, MD. Description The position of Assay Development Associate will support the assay development group of the Vaccine Production Program Labs (VPPL) in the Vaccine Research Center. This includes development of assays for viral vaccines, recombinant proteins and viruslike particles that may be used as clinical vaccine candidates. This demanding position will contribute to the clinical development of a variety of vaccine candidates.

The primary responsibilities will involve developing and conducting assays for cGMP product release and characterization. The candidate must have demonstrated experience in the development with all of the following assays for cGMP product characterization, ongoing process development and release of clinical material. HPLC methods for determination of concentration and characterization of biophysical properties for large molecule drugs. Chromatographic methods using detection techniques such as UVVis.

Particle characterization techniques such as DLS and HIAC for formulation studies. General analytical methods such as UV spectrophotometer, pH, moisture, etc. The candidate should have experience in development of critical reagents and reference standards, as well as maintenance of instruments and laboratory supplies. Knowledge of the requirements and experience developing, optimizing, qualifying and/or validating assays for cGMP products is required.

Familiarity with chromatography data acquisition and analysis software such as Empower or Chemstation is also required. The candidate will be involved in developing prequalification packages and transfer of these assays to the VRC pilot plants QC group for product release. Prior cGMP assay experience in an industrial setting, especially conducting release assays, stability and formulation analysis is highly desirable. Educational Requirements The successful candidate should have a BS/MS in Chemistry, Biochemistry or related discipline with a minimum of 5 years of relevant laboratory experience with a B.S and 3 years of experience with an M.S.

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