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Analytical Biochemistry Associate
The Analytical Biochemistry Associate is responsible for leading research and development of new and existing methods for characterization of recombinant proteins for human therapeutic use. The Associate will take a product through method development, optimization or transfer from the client (external and internal) and eventual transfer to a quality control department. This will require the ability to write development reports, test methods and associated documents, qualification and validation protocols and reports. The individual will assist in the hand on qualification/validations, training and supporting colleagues and less experienced analysts in addition to any and all needed assay development and trouble-shooting for the quality control group. In addition, this will require testing support for the Process Development group. Requires significant and effective interaction with cross-functional groups.
Essential Duties and Responsibilities
* Exercise scientifically sound judgment within defined procedures to determine appropriate course of action.
* Tabulate and graph data, and prepare technical reports for senior personnel.
* Review technical data and reports written by less experienced personnel and peers.
* Perform and transfer analytical methods from AMD to Quality Control (QC) department.
* Analyze biological material using analytical test methods and SOPs; report results to cross functional teams.
* Maintain laboratory notebooks and follow GLP and cGMP documentation requirements.
* Adhere to industry and government standards regarding aseptic technique and safe handling of biohazardous materials.
* Maintain and calibrate analytical instrumentation when necessary. Troubleshoot instrument failure and report finding to supervisor.
Education and/or Experience
Bachelorís degree or equivalent from a four-year college or university with two to five years related industrial experience in the fields of biochemistry, chemistry, biology, or biotechnology; or equivalent combination of education and experience. A general understanding of the theories for the above mentioned techniques is required.
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