Scientist II (Molecular Diagnostics), DxD Hub

Key Responsibilities

• Contribute to project scoping and preparing project proposals with in-depth understanding in clinical workflow, clinical unmet needs, technology value proposition, economic value capture, clinical deployment, and product commercialization pathway.
• Contribute to molecular test assay method development, analytical verification and clinical validation study design, planning and execution in compliance with regulatory and quality standards.
• Responsible for technical development timeline and troubleshooting.
• Contribute to the study results data curation and data analysis for downstream molecular test assay application.
• Responsible for presentation of progress, findings, and solutions to internal and external stakeholders.
• Responsible for prompt support and communications with internal and external collaborators.
• Contribute to clinical study design and clinical trial in regulated diagnostic product settings.
• Contribute to product landscape study on safety dossier and technical note approved by regulators.
• Responsible for mentoring junior scientists and refresher on the latest technology development and product landscape.
• Manage and perform lab operations activities, including general laboratory and equipment housekeeping and qualifications, and consumables purchasing.
• Responsible for good record-keeping and standard operating procedures (SOPs) implementation in accordance with confidential information requirement, quality system and regulatory guidelines.