The posting
Seeking a highly motivated senior scientist to join the ImmunoDiagnostics team, focused on developing regulated diagnostic products and services, especially in protein-based assays.
The candidate will have a wide range of exposure of different technology platform, such as but not limited to ELISA, lateral flow, flow cytometry, electrochemical sensor, and mass spectrometry. This role combines deep scientific expertise with strong project management skills. Successful candidate can be a project tech lead in the development for wide range of clinical application. Candidate will work closely with clinical and commercial stakeholders to deliver successful and impactful solutions.
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 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 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
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
