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Bioanalytical Project Leader
Evaluate suitability of validated method for study protocol, need for revalidation and participate in scheduling
Design pre-study plan and guide analysts in pre-study validation work
When assay problems occur during production, trouble shoot problem with production
Perform laboratory-based tasks, which include sampling, testing, measuring, recording, qc’ing and analyzing results to enable the laboratory to function effectively while adhering to correct procedures and health and safety guidelines
Update validation report and, if special pre-study work is done, prepare a brief summary for the final report
Perform chromatogram integration and regression analysis
Conducts all work in compliance with applicable GLPs/GMPs, SOPs, policies, safety and other regulatory requirements
Assist BPI in impact analysis of Bioanalytical Event Deviations and Investigations
Train Bioanalytical Analysts in all aspects of Extraction.
Communicate and problem-solve with BPI and Laboratory Manager for at-risk projects (not meeting timelines, resources, etc.)
Own quality of production documentation and preliminary data.
The position requires an Associates Degree in science and 4 years internal experience or a Bachelors Degree in science and 2 years experience in analytical procedures. Excellent leadership, interpersonal and communication skills are required.
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