Scientist II (Molecular Diagnostics), DxD Hub

Position Overview

Seeking a highly motivated scientist to join the Molecular Diagnostics team, focused on developing regulated clinical diagnostic products and services, especially in nucleic acid-based testing, such as but not limited to molecular approaches like next-generation sequencing (NGS)-based diagnostic assays and nucleic acid amplification-based diagnostic assays. The successful candidate will lead the development of innovative workflows for clinical applications and work closely with clinical and commercial stakeholders to deliver successful and impactful solutions.

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.

Requirements

Education

• Education in Molecular Biology, Cell Biology, Biochemistry, Genomics, Biotechnology, or a related field.

Experience

• 3-5 years of hands-on experience in molecular assay development, preferably in industrial, diagnostics or clinical laboratory setting using platforms such as NGS or PCR/qPCR technologies.
• Laboratory skills in pre-analytical and analytical techniques, including extensive knowledge and hands-on experience in molecular techniques and platforms including, but not limited to, nucleic acid extraction, PCR/qPCR, NGS, isothermal amplification and CRISPR-based diagnostic tools.
• Strong scientific foundation, demonstrated critical thinking abilities, and proven experience applying first-principles methodology.
• Strong track record in experimental design, troubleshooting, and optimisation of laboratory workflows.
• Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485 is advantageous.

Other Attributes

• A strong team player with a proactive and upbeat attitude.
• Solid academic knowledge and a critical and innovative mindset.
• Strong in identifying critical pathways and demonstrate problem-solving abilities.
• Strong and effective communication talents in complex and changing environment. Fast in the response and precise in articulation.
• Great presentation skills for a mixed audience.
• Optimistic and enthusiastic about continuous learning and professional development in the rapidly evolving field.
• Extensive industrial relation and understanding of product landscapes is advantageous.