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 stakeholder relationships, including commercial, clinical, and scientific partners, with a deep understanding of product utilities and deployment pathways to align on resources and timelines.
- Present project updates, findings, and recommendations to internal and external stakeholders.
- Lead project scoping and prepare project proposals with an in-depth understanding of clinical workflows, unmet needs, technology value propositions, economic value capture, clinical deployment, and product commercialization pathways.
- Lead data curation and analysis for downstream clinical applications.
- Provide technical guidance, decision-making, and mentoring for junior scientists.
- Lead method development, qualification, and validation studies in compliance with regulatory and quality standards.
- Ensure good experimental record-keeping and maintenance of standard operating procedures (SOPs) 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 settings using NGS technologies.
- Proficiency in molecular biology techniques, including nucleic acid extraction, PCR/qPCR, and NGS library preparation and sequencing.
- Experience 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.
- Knowledge of bioinformatics tools and pipelines for NGS data analysis, variant calling, RNA sequencing analysis, and interpretation.
- Knowledge of bioinformatics workflow languages such as Nextflow, Snakemake, and CWL is a plus.
- Familiarity with regulatory and quality standards for diagnostic assay development, e.g., ISO 13485.
- Effective communication skills and ability to work in complex, changing environments.
- Excellent presentation skills for diverse audiences.
- Strong problem-solving abilities, critical pathway identification, and innovative mindset.
- Extensive understanding of product landscapes and industrial relations.
- Enthusiastic about continuous learning and professional development in a rapidly evolving field.