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Bioanalytical Investigator
4 months ago
As the Bioanalytical Investigator, you 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. You will be required to oversee study wrap-up activities, including study data review to ensure complete and error free records and reports. You must communicate closely with QC/Data Reviewers and QA units.
You 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.
**Responsibilities**:
- **Documentation and Reports**: The BI 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 BI will be proficient in method initiation documentation, compound characterization by MS and chromatography development.
- **Study Management Activities**: Coordinate large-scale production projects. Schedule lab 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 BI 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 TPD/FDA/EMEA/GLP regulatory requirements. Assist with company visibility by participating in external meetings through posters, peer reviewed papers and presentations.
**_This position includes, but is not limited to the above responsibilities. The incumbent may also be an active member of the R&D method development team and may perform other duties as assigned._**
**Skills, knowledge & abilities**
- Strong bioanalytical GLP/GCP knowledge and method troubleshooting skills
- Mastery of the requirements for regulated bioanalysis and laboratory documentation coupled with thorough knowledge of essential laboratory procedures, including LC/MS/MS instrument maintenance and operation as well as study management as Bioanalytical Investigator
- Metabolic stability, metabolites profiling and identification as well as laboratory automation highly desirable
**Experience**: Required
- 5 year(s): M.Sc./Ph.D. with minimum 10 years experience in a regulated bioanalytical laboratory or 5 years of BI or Study Director experience in a GLP regulated environment.
**Education**: Preferred
- Bachelor or better in Science or related field
