Senior Scientist, Biomarker Laboratory, Mass Spectrometry

Role Summary

Senior Scientist, Biomarker Laboratory, Mass Spectrometry. Lead the development, validation, and execution of quantitative and qualitative mass spectrometry assays to support pharmacodynamics study and biomarker research in clinical trials as well as proteomics exploration in the Clinical Biomarker laboratory.

Responsibilities

• Build and establish LC-MS/MS workflow and data analysis pipelines
• Lead the design, development and validation of LC-MS/MS assays for target protein, peptides and other biomarker classes in complex biological matrices
• Design experimental plans and lead execution of clinical sample analysis to generate high-quality and robust biomarker data
• Serve as subject-matter expert (SME) in mass spectrometry technologies (triple quadrupole, Orbitrap, TOF)
• Collaborate with cross-functional teams including translational science, clinical biomarker scientists, clinical biomarker operations and bioinformatics teams to ensure assay and data alignment with clinical objectives
• Author and review technical documentation including method validation and clinical sample analysis protocols, reports, and SOPs
• Ensure quality control, data integrity, and timely delivery of analytical results
• Maintain accurate lab records and mentor junior scientists
• Stay current with emerging technologies (HRMS, immunoaffinity-LC-MS, hybrid approaches) and contribute to expanding LC-MS/MS-based biomarker capabilities with an innovative mindset

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 3+ years or M.S. with 5+ years of relevant industry experience in a clinical, translational or regulated environment
• Proven expertise in LC-MS/MS assay development and validation for clinical biomarkers
• Hands-on experience with biological sample preparation (plasma, serum, tissues etc.)
• Demonstrated experience designing and executing clinical biomarker/bioanalytical studies following relevant ICH, FDA, EMA and CDE guidance
• Strong analytical and problem-solving skills with the ability to think critically
• Excellent communication, organization and project management skills
• Experience in lab automation, electronic laboratory notebook (ELN), laboratory information management system (LIMS) and initial lab workflow set-up is a plus

Skills

• Mass spectrometry (LC-MS/MS) proficiency
• Biomarker assay development and validation
• Biological sample preparation (plasma, serum, tissues)
• Data analysis and interpretation for biomarker studies
• Regulatory guidance knowledge (ICH, FDA, EMA, CDE)
• Technical documentation and SOP development
• Lab automation and ELN/LIMS experience

Education

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 3+ years, or M.S. with 5+ years of relevant industry experience

Additional Requirements

• Travel: Under 10%