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Role Summary
Lead the organization's effort on test method development, validation, transfer and training with focus on chromatographic systems (i. e. GC, LC) and mass spectrum (i.e. LC-MS/MS, GC-MS/MS) to support the delivery of organization's study pipeline in the area of pre-clinical toxicology and pharmacology. Provide technical leadership to the analysts in Bioanalytics department and provide subject matter expert support for smooth day to day quality control operation.
As a technical subject matter expert, coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, global counterparts) on the testing strategy and execution delivering to the study requirements.
Participate in evaluating and technical exchange with third party laboratory to ensure outsourced project meet technical and regulatory requirements. Back up to the Coordinator Bioanalytics to review and approve test results and assist on study planning for the Bioanalytics department in work flow optimization, resourcing, procurement etc. May be conducting routine test per project requirement and capacity constrain.
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Responsibilities
- Lead the organization's effort on test method development / optimization and validation focusing on chromatographic systems (i. e. GC, LC) and mass spectrum (i.e. LC-MS/MS, GC-MS/MS) for the identification and quantitation of chemical constituents and metabolic biomarkers in complex matrices. Ahere to ICH M10 for the validation of bioanalytical methods and to ICH Q2R2 for the validation of analytical methods.
- Act as SME in the technical domain and be the point person to coordinate and liaise with cross-functional units and stakeholders (HODs, SDs, Sponsors, and global counterparts) on the testing strategy and execution. Foster a culture of collaboration and enable frequent technical exchange across the network.
- Optimize the currently available methods to ensure that they are well designed, including the use of appropriate technology (high-throughput). Provide feedbacks to the team when required. Provide technical leadership to the Bioanalytics department in the relevant technical domain; conduct training to the junior analysts and new hires; provide first-line technical support to day to day smooth quality testing.
- Conduct routine test per project requirement (GLP and non-GLP) and if required act as a study director. Plan the conduct of the experiment, book the instruments, and liaise with the required stakeholders to ensure that the project is performed before the deadline. Analyze and review data before presenting them to the relevant internal and external stakeholders.
- Back up to the Coordinator Bioanalytics to review and approve test results and assist on study planning for the Bioanalytics department in work flow optimization, resourcing, procurement etc
- Coordinate outsourced analytical activities at third party laboratory. Liaise and manage project with third party laboratory to ensure outsourced project meet technical and regulatory requirements
Requirement
- At least Bachelor Degree / M.Sc. in Chemistry, Life Sciences or related technical/scientific discipline is preferred
- Minimum 3-5 years relevant experience in analytical and bioanalytical method development, validation, and lab operations within a CRO, pharmaceutical R&D, healthcare or academic research
- In-depth knowledge and hands-on experience with analytical and bioanalytical platforms in toxicology studies and life science research.
- Capable of developing, optimizing, and validating GC, LC, LC-MSMS, and GC-MSMS methods in complex matrices.
- Extensive hands-on experience with chromatography systems and mass spectrometry.
- Experience in leading projects preferred
- Understanding of regulatory guidelines such as FDA, ICH, OECD GLP, and TGs for in vivo toxicology study and method validation preferred.
- Self-starter and highly motivated individual with excellent communication and influencing skills. Must be able to manage multiple diverse projects simultaneously.
- Good command of spoken and written English
- Proficient in MS word, Excel, Powerpoint.
