Senior Technical Specialist(J24463)

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.

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.