Bioanalytical Investigator represents the single point of study control with ultimate responsibility for the overall scientific conduct of the study. He serves to assure that the scientific, administrative and regulatory aspects of the study are controlled. He is the scientist responsible for study plan design and approval, as well as overseeing data collection, analysis and reporting. He is also responsible for drawing the final overall conclusions from the study. The candidate will have a high level of commitment to the company.
Responsibilities :
- Independently Manage Multiple Simultaneous Studies as Bioanalytical Investigator : He / she must be able to independently handle all processes related to a study project from method initiation to final report and so for multiple simultaneous studies. He / she will be required to oversee study wrap-up activities, including study data review to ensure complete and error free records and reports. Must communicate closely with QC / Data Reviewers and QA units.
- He will be responsible for ensuring that all studies under his responsibility are carried out in accordance with the Principles of GLP, which require his signature on the final study report to confirm compliance with the GLP Principles
- Documentation and Reports : The Bl will write bioanalytical method SOPs, Validation and Studies Plans and reports according to study specifications.
- Method Development and Validation : As a full member of the Bioanalytical Laboratory, the Bl will be proficient in method initiation documentation, compound characterization by MS and chromatography development.
- Study Management Activities : Coordinate large-scale production projects. Schedule Jab activities and lead study group formal and informal meetings. Conduct senior review of test data and bioanalytical work documentation. Continue to train personnel in bioanalytical and instrumental procedures. Demonstrate proficiency in managing the regulatory requirements of bioanalysis.
- Process Improvement : The Bl will be involved with process improvement activities within the company and strive to find solutions to internal problems and issues. He / She will have cultivated an active and cooperative role with internal departments, will play a key role in developing effective SOPs and Training Modules, promoting compliance in the lab, training and mentoring analysts. He / She will lead by presenting internal scientific presentations. The incumbent will act as leader in the laboratory, setting an example in adhering to regulatory and company guidelines and promoting laboratory improvement initiatives.
- External Activities : Continue development of industry knowledge as well as TPDIFDAIEMEAIGLP regulatory requirements. Assist with company visibility by participating in external meetings through posters, peer reviewed papers and presentations.
Skills, Knowledge and Abilities :