About the role
AI summarisedSenior scientist role leading regulated immuno-diagnostic product development from feasibility through design transfer and validation. Combines deep protein-assay expertise with project management to deliver clinical IVD solutions across ELISA, lateral flow, flow cytometry, electrochemical and mass-spec platforms.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Lead cross-functional project teams through different phases of product development, from feasibility to design transfer and verification/validation.
- Responsible for good records and standard operating procedures (SOPs) in accordance with confidential information requirement, quality system and regulatory guidelines.
- Mentor junior scientists and refresh the latest tech development and product landscape.
- Responsible for prompt supports and communications for internal and external stakeholders.
- Responsible for assay planning, and execution, analysing experimental data, troubleshoot technical challenges.
- Responsible for presentation for progress, finding, and solution to internal and external stakeholder
- Responsible for technical development timeline, budgets and resources.
- Contribute to product landscape study on safety dossier and technical note approved by regulators.
- Contribute to clinical study design, clinical trial in regulated diagnostic product settings.
Requirements
- Education in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, or a related field.
- At least 6-8 years of hands-on experience in protein-based assay development or IVD product development, preferably in industrial, diagnostics or clinical laboratory setting, with at least 2-3 years in a project or team leadership capacity.
- Strong scientific foundation, demonstrated critical thinking abilities, and proven experience applying first-principles methodology.
- Strong in experimental design, troubleshooting, and optimisation of laboratory workflows.
- Laboratory skills in techniques in pre-analytical and analytical, including extensive knowledge and hand-on experience in protein-based techniques.
- Familiar with regulatory and quality standards for diagnostic assay development e.g. ISO13485.
- Demonstrated ability to manage complex projects and coordinate cross-disciplinary teams.
- Training or certification in project management (e.g. PMP) is advantageous.
- Highly multi-tasking with prompt response.
- Ability to articulate complex matter, which is guided by a great feedback loop.
- Great presentation skills for a mixed audience.
- Strong in identifying critical pathways and problem-solving abilities.
- Solid academic knowledge and a critical and innovative mindset.
- Extensive industrial relation and understanding of product landscapes.
- Optimistic and enthusiastic about continuous learning and professional development in the rapidly evolving field.