Analytical Biochemistry Associate II

The Analytical Biochemistry Associate II is responsible for leading research and development of new and existing methods for characterization of recombinant proteins for human therapeutic use. This individual will take a product through method development and eventually transfer it to a Quality Control Department. In addition, this individual will assist in training and supporting less experienced analysts with lab support. Work such as reagent preparation, record keeping, equipment calibration and qualification, and cGMP documentation may be required. Job Requirements: perform research and development of new and existing methods for characterization of recombinant proteins, ability to design and execute developmental activities, use technical proficiency as well as scientific creativity and independent thought and collaboration with others to solve bioanalytical assay related problems, test recombinant proteins using the following instruments/techniques (UV spectrophotometer, HPLC, Capillary Electrophoresis, SDS-PAGE, FACE Glycosylation Profiling, ELISA, Endotoxin, and other related methods), exercise scientifically sound judgment within defined procedures to determine appropriate course of action, tabulate and graph data, prepare technical reports for senior personnel, perform and transfer analytical methods from AMD to Quality Control (QC) department, analyze biological material using analytical test methods and SOPs as well as report results to cross functional teams, draft and revise GMP documentation to be used by the analytical quality control department (such as test methods, formulation methods, and SOPs), write protocols and reports, maintain laboratory notebooks and follow GLP and cGMP documentation requirements.

Candidates must have experience with troubleshooting instrument failure and identifying areas for improvement and increased efficiency. This Associate must be able to assist in implementing approved changes, comply with all rule (safety policies, practices, and procedures), and participate in proactive team efforts to achieve departmental and company goals. A Bachelor's degree or equivalent from a four-year college or university with one to two years of related industrial experience in the fields of biochemistry, chemistry, biology, or biotechnology or the equivalent combination of education and experience is required. A general understanding of the theories for the above mentioned techniques is required. Candidates must adhere to industry and government standards regarding aseptic technique and safe handling of biohazardous materials as well as maintain and calibrate analytical instrumentation when necessary.