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General Description:

We are seeking an accomplished and self-motivated Senior Scientist with deep expertise in mass spectrometry-based bioanalysis to join our Clinical Biomarker laboratory. This role will 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. The role requires a strong background in bioanalytical chemistry, protein/peptide quantification in biological matrices, deep understanding of relevant regulatory guidance, as well as hands-on experience in mass spectrometry-based biomarker method development, validation and clinical sample analysis.

Essential Functions of the job:

+ 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

Supervisory Responsibilities:

+ This role is initially an individual contributor. May supervise lab scientists as the team grows.

Computer Skills:

Proficiency in general software such as Microsoft Office (Word, Excel, PowerPoint), Outlook, Zoom, Teams as well as task-related systems e.g. Analyst, LIMS, ELN

Other 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.

**Travel:** Under 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.