The Scientist will be assigned by management as Bioanalytical Principal Investigator and is the first point of contact for project manager and clients for laboratory services;
Manage and conduct method development, qualification , validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices;
Support and mentor analysts, troubleshoot and resolves issues with methods under their responsibility or technical issues in the laboratory when scientific expertise is needed;
The Scientist is also encouraged to introduce new technologies when required or recommend improvements to existing technologies as needed;
Provide a report and/or reporting of results, within study timelines and ensure any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate;
May be required to review and provide comments and recommendations, as needed to the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed;
Write, review and updated method SOP as needed;
Participate in meetings with clients, conferences and scientific outreach;
Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies;
The Scientist will respect Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures.
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