Overview:
The Research Scientist will support the full lifecycle R&D of LC-MS qualitative quantitative analytical assays fclinical diagnostics translational research. Collaborate with external clinical partners including tertiary hospitals, clinical labs, CROs academic institutions to deliver clinical research projects, conduct technical troubleshooting method optimisation, ensure all R&D activities fully comply with ISO15189 quality standards relevant regulatory requirements.
Responsibilities:
• Responsible fend-to-end development, optimisation full methodological validation of LC-MS qualitative & quantitative methods fIVD clinical diagnosis translational research, covering biomarker testing, therapeutic drug monitoring, metabolomics profiling other clinical scenarios.
• Serve as core technical member fexternal clinical collaborative projects. Communicate cooperate with partners, tertiary hospitals, clinical laboratories, CROs university translational research teams, design technical schemes, draw up research roadmaps, manage project timelines, conduct experiments resolve daily technical issues.
• Summarize standardize mature clinical mass spectrometry testing workflows application protocols based on project practice.
• Solve technical data abnormal issues in clinical LC-MS testing research, complete data analysis, deliver effective optimization improvement solutions. Investigate resolve analytical, instrument, data-related issues through systematic root-cause analysis, delivering effective corrective preventive actions.
• Follow clinical laboratory industry standards, ISO15189 quality management system clinical trial regulatory requirements, ensure all R&D collaborative projects are implemented in compliance with relevant specifications.
• Participate in domestic international academic conferences technical exchanges maintain stable long-term cooperative relationships with clinical research partners.
Qualifications / Education required:
• Masters degree above in Analytical Chemistry, Clinical Laboratory Medicine, Biomedical Engineering, Pharmaceutical Analysis, Biochemistry, Life Sciences, other related fields.
Experience required:
• 5+ years of LC-MS method development experience.
• Candidates with experience in hospital clinical laboratory, IVD enterprise application R&D, CRO clinical bioanalysis university translational medicine research are preferred.
• Familiar with Waters mass spectrometry instrument platform is a plus.
Aptitude / skills required:
• Familiar with LC-MS instrument principles, sample pretreatment techniques, chromatographic mass spectrometric condition optimization, complete methodological verification procedures.
• Possess solid data analysis problem-solving capabilities with a rigorous research mindset standardized documentation & experimental operation skills.
• Knowledgeable in mainstream clinical mass spectrometry application scenarios industry norms, familiar with ISO15189 quality system basic clinical trial compliance requirements.
• Capable of independent project delivery cross-institution technical communication, able to undertake drive clinical collaborative research projects independently.
• Available fregular business travel (around 30%).
• Good English listening speaking ability is preferred.
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