About the role
AI summarisedMid-level scientist role focused on developing regulated clinical diagnostic products, particularly nucleic acid-based testing using NGS and PCR technologies. Involves leading assay development from concept through clinical validation while managing cross-functional projects and mentoring junior staff.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Contribute to molecular test assay method development, analytical verification and clinical validation study design, planning and execution in compliance with regulatory and quality standards
- Contribute to the study results data curation and data analysis for downstream molecular test assay application
- Lead project teams to ensure the successful delivery of molecular diagnostics development milestones, leveraging effective project planning, resource management, and risk mitigation strategies
- Establish, manage, and monitor project plans, timelines, budgets, and deliverables, ensuring alignment with regulatory requirements, quality standards, and company objectives
- Facilitate regular project meetings, document minutes and action items, and communicate progress transparently to internal and external stakeholders
- Identify and resolve project bottlenecks, technical risks, and resource gaps, escalating issues as needed to management
- 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
- 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 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 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
- Project management experience in a laboratory, clinical or diagnostic product development context
- Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485 is advantageous