Senior Research Scientist at Waters Corporation in CN-Shanghai

Job description

• The Senior Research Scientist will lead the development, optimisation, validation, and clinical application of LC-MS-based qualitative and quantitative assays for clinical diagnostics and translational research. The role requires scientific leadership in external clinical collaborations, spanning major hospitals, clinical laboratories, CROs, and academic research institutions, while ensuring compliance with applicable quality and regulatory requirements.

Responsibilities

• Responsible for the full lifecycle development, optimization and methodological validation of LC-MS qualitative and quantitative methods for clinical diagnostics (IVD) and translational research, covering biomarker detection, therapeutic drug monitoring, metabolic profiling and other clinical application scenarios.
• Act as a key technical contributor for external clinical collaborative projects. Communicate and cooperate with partners, tertiary hospitals, clinical laboratories, CROs and university translational research teams. In charge of technical solution design, research roadmap formulation, project progress management, experimental implementation and daily technical troubleshooting.
• Summarize and standardize mature clinical mass spectrometry testing workflows and application protocols based on project practice.
• Solve technical and data abnormal issues in clinical LC-MS testing and research, complete data analysis, and deliver effective optimization and improvement solutions. Investigate and resolve analytical, instrument, and data-related issues through systematic root-cause analysis, delivering effective corrective and preventive actions.
• Follow clinical laboratory industry standards, ISO15189 quality management system and clinical trial regulatory requirements, ensure all R&D and collaborative projects are implemented in compliance with relevant specifications.
• Participate in domestic and international academic conferences and technical exchanges and maintain stable and long-term cooperative relationships with clinical and research partners.
• Provide scientific mentorship and technical guidance to junior scientists and laboratory staff, supporting capability development within the organization.

Requirements

• Master's degree or above in Analytical Chemistry, Clinical Laboratory Medicine, Biomedical Engineering, Pharmaceutical Analysis, Biochemistry, Life Sciences, or other related fields.
• 10+ years of LC-MS method development experience.
• Candidates with experience in hospital clinical laboratory, IVD enterprise application R&D, CRO clinical bioanalysis or university translational medicine research are preferred.
• Familiar with Waters mass spectrometry instrument platform is a plus.
• Familiar with LC-MS instrument principles, sample pretreatment techniques, chromatographic and mass spectrometric condition optimization, and complete methodological verification procedures.
• Possess solid data analysis and problem-solving capabilities with a rigorous research mindset and standardized documentation & experimental operation skills.
• Knowledgeable in mainstream clinical mass spectrometry application scenarios and industry norms, familiar with ISO15189 quality system and basic clinical trial compliance requirements.
• Capable of independent project delivery and cross-institution technical communication, able to undertake and drive clinical collaborative research projects independently.
• Available for regular business travel (around 30%).
• Good English listening and speaking ability is preferred.

Skills

Required

• LC-MS method development
• LC-MS instrument principles
• Sample pretreatment techniques
• Methodological verification procedures
• Data analysis and problem-solving
• Rigorous research mindset
• ISO15189 quality system
• Clinical trial compliance requirements
• Independent project delivery
• Business travel (around 30%)