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A*STAR

Scientist II (Molecular Diagnostics), DxD Hub

A*STAR
ResearchSingaporeFull-time1 months ago
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About the role

AI summarised

DxD Hub is seeking a Scientist II to join the Molecular Diagnostics team, focusing on developing regulated clinical diagnostic products using nucleic acid-based testing, particularly NGS-based assays. The role involves leading assay development, analytical verification, clinical validation, and collaborating with stakeholders to deliver impactful solutions.

ResearchFull-timeDiagnostics Development Hub

Key Responsibilities

  • Contribute to project scoping and preparing of 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 in Molecular Biology, Cell Biology, Biochemistry, Genomics, Biotechnology, or a related field.
  • 3-5 years of hands-on experience in molecular assay development, preferably in industrial, diagnostics or clinical laboratory setting using NGS 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, NGS library preparation, target enrichment, PCR/qPCR and sequencing.
  • Strong scientific foundation, demonstrated critical thinking abilities, and proven experience applying first-principles methodology.
  • Strong background in experimental design, troubleshooting, and optimization of laboratory workflows.
  • Competent with NGS platforms (e.g. Illumina, Oxford Nanopore, PacBio) and associated data analysis tools.
  • Knowledgeable with bioinformatics tools and pipelines for NGS data analysis, variant calling, RNA sequencing analysis, interpretation and annotation of result.
  • Knowledge of bioinformatics workflow languages such as Nextflow, Snakemake and Common Workflow Language (CWL) is advantageous.
  • Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485 is advantageous.