US-NY-Pearl River: Research Scientist I Bio

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Date: 01-Jul-2008

Research Scientist I Bio

Job Summary

The primary purpose of this position is to assist in clinical testing of phase 2/3 studies supporting the 13V pneumococcal vaccine candidate in adults and infants. Specifically, the analyst will assay human serum samples using the 13V Pneumococcal Opsonophagocytic Assay. The position also includes performing assay development experiments and data review of clinical and experimental assays. The job involves performing other tasks as assigned, related to clinical serology functional bioassays, ELISA, when necessary. This position operates with limited supervision. All of the above includes practicing laboratory safety at all times and efforts toward GMP compliance.

Job Responsibilities

Perform 13V Pneumococcal Opsonophagocytic Assay on phase 2/3 clinical trial samples and development work in support of assay improvement.

Assist in experiments for improving OPA (or other bioassay) performance and robustness in support of method validation.

Screen, test, and QC necessary reagents (such as control sera, complement, and creation of a proficiency panel) that are needed for the functional bioassays to support clinical testing.

Assist in updating and writing documents associated with bio-functional assays, including information/data archiving, SOP and status reports. Documentation involves use of the following SOFTWARE: Microsoft Excel, Microsoft Word, Win ELISA, Soft Max Pro, JMP, VAX, Sorcerer, Macintosh data processing SOFTWARE.

Assist in ordering supplies from internal inventory and order/prepare reagents/supplies necessary for bio-functional assay work.

Satisfactorily completes all GMP/GLP and safety training in conformance with Departmental requirements.

Where applicable, performs job responsibilities in compliance with GMP/GLP and all other regulatory agency requirements.

Performs other tasks as assigned.

Basic Qualifications

BS (or equivalent) + 6 yrs or MS (or equivalent) + 4 yrs.

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/