Deskripsi Pekerjaan
Join Waters Corporation as a visionary Director of R&D, leading the scientific strategy for Clinical Flow Cytometry assay and Companion Diagnostic (CDx) development in Singapore. You will serve as the ultimate technical authority, guiding projects from initial feasibility studies through to successful clinical validation and commercial launch. In this pivotal role, you will bridge the gap between cutting-edge separation science and clinical diagnostics, ensuring our innovative solutions meet stringent regulatory standards while driving patient impact.
Waters is a global leader in analytical instruments and software, and we are looking for a seasoned leader to spearhead our next generation of clinical tools. You will collaborate with cross-functional teams including Regulatory Affairs, Clinical Operations, and Product Management to deliver world-class diagnostic solutions. If you are passionate about transforming healthcare through precise measurement and scientific leadership, this is your opportunity to shape the future of clinical diagnostics at a Fortune 500 company.
Tanggung Jawab
- Serve as the primary scientific authority for the development of clinical flow cytometry assays and CDx solutions, ensuring technical excellence.
- Lead the R&D strategy from feasibility and design through to validation, regulatory submission, and launch.
- Oversee the execution of complex clinical trials and ensure data integrity across all development phases.
- Collaborate closely with regulatory bodies (e.g., HSA, FDA) to ensure compliance with local and international clinical validation requirements.
- Mentor and develop a high-performing team of scientists and engineers, fostering a culture of innovation and continuous improvement.
- Identify emerging market trends and technological advancements in the field of flow cytometry and personalized medicine.
- Prioritize resources effectively to meet critical project milestones and timelines.
Kualifikasi
- Advanced degree (PhD or MD) in Immunology, Molecular Biology, Flow Cytometry, or a related scientific field.
- Minimum of 10+ years of experience in R&D, specifically within clinical diagnostics, flow cytometry, or companion diagnostic development.
- Proven track record of leading cross-functional teams and managing large-scale development projects.
- Deep understanding of regulatory frameworks for in vitro diagnostics (IVD) and clinical laboratory standards (CLIA, ISO 13485).
- Strong expertise in assay development, validation, and troubleshooting of complex instrumentation.
- Excellent communication skills, with the ability to present complex scientific concepts to diverse stakeholders.
- Fluency in English and a commitment to operational excellence.