Scientist II (Molecular Diagnostics), DxD Hub

Position Overview Seeking a highly motivated scientist to join the Molecular Diagnostics team, focused on developing regulated clinical diagnostic products and services, especially in nucleic acid-based testing, such as but not limited to molecular approaches like next-generation sequencing (NGS)-based diagnostic assays 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 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 molecular test assay method development, analytical verification and clinical validation study design, planning and execution in compliance with regulatory and quality standards. Contribute to the study results data curation and data analysis for downstream molecular test assay application. 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. Contribute to clinical study design and clinical trial in regulated diagnostic product settings. Contribute to product landscape study on safety dossier and technical note approved by regulators. Responsible for mentoring junior scientists and refresher on the latest technology development and product landscape. Manage and perform lab operations activities, including general laboratory and equipment housekeeping and qualifications, and consumables purchasing. Responsible for good record-keeping and standard operating procedures (SOPs) implementation in accordance with confidential information requirement, quality system and regulatory guidelines. Requirements Education Education in Molecular Biology, Cell Biology, Biochemistry, Genomics, Biotechnology, or a related field. Experience 3-5 years of hands-on experience in molecular assay development, preferably in industrial, diagnostics or clinical laboratory setting using platforms such as NGS or PCR/qPCR technologies. Laboratory skills in pre-analytical and analytical techniques, including extensive knowledge