Senior Scientist (ImmunoDx), DxD Hub Full-time

Senior Scientist (ImmunoDx), DxD Hub

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 to different technology platforms, such as but not limited to ELISA, lateral flow, flow cytometry, electrochemical sensors, and mass spectrometry. This role combines deep scientific expertise with strong project management skills.

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

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 requirements, quality system, and regulatory guidelines.
• Responsible for mentoring junior scientists and refreshing the latest tech development and product landscape.
• Responsible for prompt supports and communications for internal and external stakeholders.
• Responsible for assay planning, and execution, analyzing experimental data, troubleshooting technical challenges.
• Responsible for presentation for progress, findings, and solutions to internal and external stakeholders.
• Responsible for technical development timelines, budgets, and resources.
• Contribute to project scoping and preparing project proposals with in-depth understanding of 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 settings, 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 track record in experimental design, troubleshooting, and optimization of laboratory workflows.
• Laboratory skills in techniques in pre-analytical and analytical, including extensive knowledge and hands-on experience in protein-based techniques.
• Familiarity 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 matters, which is guided by a great feedback loop.
• Great presentation skills for a mixed audience.
• Strong in identifying critical pathways and demonstrating 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.