Diagnostics Development Hub (DxD Hub) is seeking a highly motivated scientist to join the ImmunoDiagnostics team, focused on developing regulated diagnostic products and services, especially in protein-based assays such as but not limited to ELISA, lateral flow assay, flow cytometry diagnostics assay and/or mass spectrometry 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. This is a 2-years contract position.
Key Responsibilities
- Responsible for good records and standard operating procedures (SOPs) in accordance with confidential information requirement, quality system and regulatory guidelines.
- Responsible for mentoring junior and refreshing the latest tech development and product landscape.
- Responsible for prompt supports and communications for internal and external collaborators.
- Responsible for assay planning and execution.
- Responsible for presentation for progress, finding, and solution to internal and external stakeholder.
- Responsible for technical development timeline and troubleshooting.
- Contribute to 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.
- 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.
- Manage and perform lab operations activities, including general laboratory and equipment housekeeping and qualifications, and consumables purchasing.
Requirements
- Education in Biochemistry, Cell Biology, Molecular Biology Biotechnology, or a related field.
- At least 5 years of hands-on experience in protein-based assay development, preferably in industrial, diagnostics or clinical laboratory setting.
- Laboratory skills in techniques in pre-analytical and analytical, including extensive knowledge and hand-on experience in protein-based techniques.
- Strong track record in experimental design, troubleshooting, and optimisation of laboratory workflows.
- Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485.
- Ability to be 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 demonstrate 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.
- A strong team player with a proactive and upbeat attitude.
