|
Position Overview:
Seeking a highly motivated Scientist/Project Manager to join the Molecular Diagnostics team, focused on developing clinical diagnostic products, especially in genetic testing, based on molecular approaches such as, but not limited to, next-generation sequencing (NGS)-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:
-
Manage project and stakeholders including commercial, clinical, and scientific partners, with a deep understanding of the product utilities and deployment pathway to align on the resource and timeline.
-
Present project updates, findings, and recommendations to internal and external stakeholders.
-
Lead 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.
-
Lead the data curation and data analysis for downstream clinical application.
-
Provide technical decision, guidance and mentoring for junior scientists.
-
Lead method development, qualification, and validation studies in compliance with regulatory and quality standards.
-
Responsible for good experimental record-keeping and standard operating procedures (SOPs) maintenance in accordance with regulatory guidelines.
Requirements:
-
Education in Molecular 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 molecular biology techniques, including nucleic acid extraction, PCR/qPCR, and NGS library preparation and sequencing.
-
Competent with NGS platforms (e.g. Illumina, Oxford Nanopore, PacBio) and associated data analysis tools.
-
Strong background in experimental design, troubleshooting, and optimization of laboratory workflows.
-
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 a plus.
-
Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485.
-
Strong effective communicator and team player who is able to adapt in complex and changing environment.
-
Great presentation skills for a mixed audience.
-
Strong in identifying critical pathway, demonstrated problem-solving abilities and innovative mindset.
-
Extensive industrial relations and understanding of product landscapes.
-
Optimistic and enthusiastic about continuous learning and professional development in the rapidly evolving field.
|