Key accountabilities:
Provide technical oversight and scientific guidance for laboratory operations, ensuring alignment with CAP, CLIA, and GLP regulations.
Review and provide recommendations on new/revised SOPs, validation plans/reports, and other critical technical documents.
Lead troubleshooting for complex technical issues, including assay deviations, instrument performance, and unexpected results.
Provide expert consultation on method validation, method transfer, and new platform implementation.
Participate in technical discussions with clients, sponsors, and regulatory agencies as needed, providing expert input on laboratory methodologies and results.
Mentor and train junior staff on technical competencies, assay principles, and regulatory requirements.
Support the Laboratory Director in strategic technical decisions and regulatory inspections.
Other tasks assigned by the Department Leader.
任职要求
Core business/Functional skills and education requirements:
Bachelor’s degree or above in Clinical Laboratory Science, Medical Technology, Medicine, or a related field from an accredited institution. Master’s or Ph.D. strongly preferred. MD, or equivalent medical degree in laboratory medicine is highly preferred.
Minimum 10 years of working experience in a CAP- or CLIA-accredited clinical laboratory.
Deep knowledge in clinical biochemistry, immunology, and hematology. Proven ability to troubleshoot complex assays and lead method validation/transfer activities.
Fluent in both English and Chinese.
