Scientist II (Molecular Diagnostics), DxD Hub Full-time

Scientist II (Molecular Diagnostics), DxD Hub

Seeking a highly motivated scientist to join the Molecular Diagnostics team, focused on developing regulated diagnostic products and services, especially in genetic testing, and based on molecular approaches such as but not limited to next-generation sequencing (NGS)-based and nucleic acid amplification-based diagnostic 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 position additionally includes project management responsibilities across all phases of assay and product development.

Key Responsibilities

• Lead project teams to ensure the successful delivery of molecular diagnostics development milestones, leveraging effective project planning, resource management, and risk mitigation strategies.
• Establish, manage, and monitor project plans, timelines, budgets, and deliverables, ensuring alignment with regulatory requirements, quality standards, and company objectives.
• Facilitate regular project meetings, document minutes and action items, and communicate progress transparently to internal and external stakeholders.
• Identify and resolve project bottlenecks, technical risks, and resource gaps, escalating issues as needed to management.
• Responsible for good record-keeping and standard operating procedures (SOPs) implementation in accordance with confidential information requirement, quality system and regulatory guidelines.
• Responsible for mentoring junior scientists and refresher on the latest technology development and product landscape.
• Responsible for assay planning and execution.
• Responsible for presentation of progress, findings, and solutions 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 and 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 Molecular Biology, Biochemistry, Genomics, Biotechnology, or a related field.
• Project management experience in a laboratory, clinical or diagnostic product development context is strongly preferred.
• 3-5 years of hands-on experience in molecular assay development, preferably in industrial, diagnostics or clinical laboratory setting.
• Laboratory skills in pre-analytical and analytical techniques, including extensive knowledge and hands-on experience in molecular 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 highly multi-task, with prompt response.
• Ability to articulate complex matters, which is guided by effective 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.
• Strong team player with a proactive and upbeat attitude.