About the role
AI summarisedJoin the Molecular Diagnostics team to drive the development of regulated clinical diagnostic products and services, specializing in nucleic acid-based testing. This role involves leading innovative workflow development for clinical applications and collaborating with commercial stakeholders to deliver impactful solutions, encompassing full project management responsibilities across assay and product development phases.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Contribute to molecular test assay method development, analytical verification, and clinical validation study design, planning, and execution compliant with regulatory standards.
- Lead project teams to ensure the successful delivery of molecular diagnostics development milestones through effective planning and risk mitigation.
- Establish, manage, and monitor project plans, timelines, budgets, and deliverables aligned with regulatory requirements.
- Facilitate project meetings, document action items, and transparently communicate progress to internal and external stakeholders.
- Contribute to clinical study design and clinical trials within regulated diagnostic product settings.
- Mentor junior scientists on the latest technology developments and product landscape.
- Maintain good record-keeping and implement SOPs according to 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 settings.
- Proficiency with molecular techniques including nucleic acid extraction, PCR/qPCR, NGS, isothermal amplification, and CRISPR-based diagnostic tools.
- Strong scientific foundation with proven critical thinking abilities and application of first-principles methodology.
- Demonstrated track record in experimental design, troubleshooting, and optimization of laboratory workflows.
- Project management experience within a laboratory, clinical, or diagnostic product development context.