Roles and Responsibilities:
Scientific and Business Strategy
* Provide strategic input to CEO and Director, Clinical Diagnostic Laboratory on the positioning and value proposition of molecular focused clinical diagnostic laboratory
* Analyze competitive landscape of local and regional molecular diagnostic labs
* Propose and continuously refine the test menu for clinical diagnostic laboratory
* To identify new tests to implement, either through internal tech-transfer from other companies or via in-licensing of commercially available tests. To assess and project the market potential of new tests and to contribute to the Business Development process required to bring in the identified new clinical tests.
Laboratory Technical Operations
Be overall responsible for all scientific and technical operations including:
* The setting up of the laboratory
* Development, validation, implementation, and optimization of molecular diagnostic assays, with a focus on
o NGS assays for oncology applications
o PCR assays for oncology applications
o PCR assays for infectious disease applications
o Other molecular diagnostic assays for other disease areas
o Derivation and implementation of QC process and results reporting workflow for all new tests
* Evaluation and selection of equipment and consumables
* Recruitment, training and management of scientific officers and medical technologists
* Develop, implement, and continuously improve standard operating procedures
* Develop, implement, and continuously improve risk assessment policies and protocol
* Carry on scientific and clinical research studies
Quality and Regulatory
* Be responsible for MOH-licensing Inspection and CAP Accreditation inspection
* Work with quality and regulatory team to develop, implement and continuously improve lab's quality, regulatory and safety standards to ensure compliance with all applicable local and global regulatory requirement, including but not limited to PHMC, ISO15189, CAP.
* To oversee the Laboratory's EQA programs to ensure that PTs and other EQA testing are sufficient, promptly done and correctly reported.
* To oversee the Laboratory preventive maintenance (PM) schedule to ensure the PM for all testing equipment and instruments are up to date.
* To assemble the Quality Monitoring and Process Improvement (QMPI) team to carry out regular review of quality of testing (TAT and rejection rates) and identify laboratory safety issues.
* To implement a LIMS and implement a reporting workflow for new testing services.
* To implement an occurrence reporting workflow, and to implement a customer feedback and complaints procedure.
* Any additional duties as assigned by CEO.
