Principal Scientific Officer
Technical & Assay Leadership (LDT Design, Development & Validation):
Own end-to-end design, development, and analytical validation of laboratory-developed tests (LDTs) and molecular/NGS assays — analytical sensitivity/specificity, precision, accuracy/trueness, linearity and reportable range, reference intervals, interference, carryover, and specimen stability — prior to clinical implementation.
Lead method verification and transfer for new tests, panel updates, and platform or reagent changes, ensuring equivalence to previously validated methods.
Support the preparation of technical documentation for laboratory-developed test (LDT) regulatory notifications and validation records, in coordination with the CGO and QMO.
Provide technical oversight and final-level review of library preparation and sequencing runs, and act as bioinformatics QC liaison for the section.
Own instrument qualification (IQ/OQ/PQ), calibration, and preventive-maintenance programme for section equipment.
Own reagent and vendor qualification, including lot-to-lot verification, for critical section reagents.
Troubleshoot assay and instrument performance issues, leading root-cause investigation for technical deviations.
Operational and Regulatory Compliance:
Maintain the on-site presence / duty-coverage arrangements and personal qualification standing required for continued appointment eligibility.
Ensure the section enrols in, and performs satisfactorily for, the relevant external quality assessment / proficiency testing programme for every test provided, and prepare results and corrective actions.
Quality & Technical Competency:
Support execution of the section's quality management system, including document control, non-conformance / CAPA, and internal audit participation.
Lead non-conformance investigation and root-cause analysis for technical/assay-related deviations within the section.
- Provide technical supervision and mentoring to Clinical Lab Officers and Senior Clinical Lab Officers performing assay work within the section, including design and delivery of the section's technical competency-assessment programme.
- Support the QMO as primary technical point of contact for CAP, HCSA, and ISO 15189 inspections and accreditation readiness for the section.
Ad Hoc Duties:
- Other reasonable duties commensurate with the role as assigned by the CGO or laboratory management.