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Bioanalytical Project Leader - United States  

Celerion (company)


Posted on : 09 April 2017

Project Description

  • 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.