Scientist - Cell Bioassays ID-4081
Role Summary
Lead the organization&aposs effort on test method development, validation, transfer and training with focus on cell-based and ligand binding assays using advanced system (i.e., Luminex, FACS, ELISA), clinical pathology using basic system (i.e., COBAS, STA, DXC, SYSMEX) and in-vitro cytotoxicity and genotoxocity assays to support the delivery of organization&aposs study pipeline in the area of pre-clinical toxicology and pharmacology.
Provide technical leaderships to the analysts in Cell Bioassays department and support for 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.
Review and approve test results and assist on study planning for Cell Bioassays department in work flow optimization, resourcing, procurement etc. May be conducting routine test per project requirement and capacity constrain.
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Responsibilities
- Act as a study director for the conduct of studies under Good Laboratory Practices (GLP). Ensure that all documents are prepared according to GLP standards and within the required timeframe. Supervise or perform the experimental phase of the study for both regulatory and exploratory studies. At the end of the study, ensure all documents are completed and participate in internal and external audits.
- Lead the organizations effort on test method development/optimization and validation focusing on cell-based and ligand binding assays (i.e. Luminex, FACS, ELISA) for the identification and quantitation of chemical constituents and metabolic biomarkers in complex matrices. Conduct in-vitro assays (AMES, MLA, WST8, NRU) for endpoint procedures using cell and bacterial cultures
- Provide technical leaderships to the analysts in Cell Bioassays department in the relevant technical domain; conduct training to the junior analysts and new hires; provide first-line technical support for daily smooth quality testing
- Coordinate outsourced bioassay activities at third party laboratory. Participate in evaluating and technical exchange with third party laboratory to ensure outsourced project meet technical and regulatory requirements
- 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
- Review and approve test results and assist on study planning for Cell Bioassays department in work flow optimization, resourcing, procurement etc
- Conduct routine test per project requirement and capacity constrain, and assigned with operational tasks and improvement projects. The routine measurements includes performing cytotoxicity assays under the scope of ISO 17025
Requirement
- At least Bachelor Degree / M.Sc. in Chemistry, Life Sciences or related technical/scientific discipline is preferred
- Minimum 3 years relevant experience with technical and scientific knowledge with focus on bioassays method development, validation and laboratory operations, with a CRO, R&D unit within pharmaceutical or healthcare industries, or translational research organizations
- In-depth knowledge and preferably hands-on experience in workflows related to toxicology studies and life science research.
- Must possess experience in conducting studies under Good Laboratory Practices (GLP).
- Independent ability to develop, optimize, and validate assays such as Luminex, FACS, and ELISA-based methods in complex matrices.
