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.