Scientist II (ImmunoDx IVD), DxD Hub Full-time

Scientist II (ImmunoDx IVD), DxD Hub

Seeking a highly motivated 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 to different technology platforms, such as but not limited to ELISA, lateral flow, flow cytometry, electrochemical sensor, and mass spectrometry.

The successful candidate can be a tech lead in the development for a wide range of clinical applications and will work closely with clinical and commercial stakeholders to deliver successful and impactful solutions.

Key Responsibilities

• Responsible for good records and standard operating procedures (SOPs) in accordance with confidential information requirement, quality system and regulatory guidelines.
• Mentor junior and refresh the latest tech development and product landscape.
• Provide prompt supports and communications for internal and external collaborators.
• Assay planning and execution.
• Responsible for presentation for progress, finding, and solution to internal and external stakeholders.
• 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.
• Strong scientific foundation, demonstrated critical thinking abilities, and proven experience applying first-principles methodology.
• Strong track record in experimental design, troubleshooting, and optimization of laboratory workflows.
• Laboratory skills in techniques in pre-analytical and analytical, including extensive knowledge and hand-on experience in protein-based techniques.
• Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485.
• 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.