Bioanalytical Project Leader - United States
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- Our company is a leading international research organization, has a full-time position open as an Project Leader in our Bio-analytical Division.
- As an Project Leader you will provide scientific and quality control review on production projects.
- You will work independently on routine production and perform complex validation working consultation with other Bio-analytical Project Leaders.
Essential Functions include
- Evaluate suitability of validated method for study protocol, need for re-validation 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.