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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Scientist to own LC-MS/MS - **Company:** C S Bio Co. - **Location:** Milpitas, CA, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Data Integrity, Model Validation - **Published:** September 24, 2026 - **Apply:** https://www.thejobnetwork.com/job/48c4e949-116a-4f0d-905d-6484a6e019a3/senior-scientist-lcmsms ## About the Role * Ph.D. in analytical chemistry, biochemistry, or a related field with 4-7 years of hands-on LC-MS/MS experience; or M.S./B.S. with 8-12 years of experience in GLP laboratory environments and GMP environments. * Demonstrated, hands-on expertise in developing and validating LC-MS/MS bioanalytical methods for quantitation of peptides or other biologics in biological matrices (e.g., plasma, serum) to support PK studies. * Direct, hands-on experience with regulated bioanalytical method validation and study sample analysis under ICH M10 (and/or the FDA Bioanalytical Method Validation guidance) in support of PK studies. * Strong working knowledge of GLP (21 CFR Part 58) as applied to nonclinical PK/bioanalytical studies, GCLP principles as applied to clinical-phase human sample analysis, 21 CFR Part 11 (data integrity), ICH Q2(R2), and ICH M10. * Proven ability to author validation protocols/reports and submission-ready analytical documentation, and to lead OOS/OOT investigations. * Ability to work independently as the sole MS owner while collaborating across CMC, QA, and clinical functions. ## Description Yowei Therapeutics is seeking a Senior Scientist to own LC-MS/MS for regulated bioanalytical testing in support of pharmacokinetic (PK) studies for the company's peptide clinical programs. This is a hands-on, single-owner role responsible for the full method lifecycle - development and validation. Core duties are included below., * Develop, qualify, and validate LC-MS/MS bioanalytical methods for quantitation of peptide therapeutics and, where required, their metabolites in biological matrices (plasma, serum, tissue) to support nonclinical and clinical PK studies. * Execute full bioanalytical method validation to ICH M10 - selectivity, specificity, calibration curve and range, within- and between-run accuracy and precision, matrix effect and recovery, carryover, dilution integrity, and the complete stability panel (stock/working solution, benchtop, freeze-thaw, processed/autosampler, and long-term matrix stability). * Design and manage study sample analysis runs, including run acceptance criteria, calibration and QC schemes, reassay rules, and incurred sample reanalysis (ISR). * Establish fit-for-purpose peptide sample preparation - protein precipitation, solid-phase extraction, and hybrid immunocapture-LC-MS/MS where sensitivity demands - using stable-isotope-labeled internal standards and surrogate-peptide (signature peptide) strategies as appropriate. * Address peptide-specific bioanalytical challenges, including non-specific/adsorptive loss, protease-driven instability, and quantitation of endogenous or endogenous-like peptides (e.g., thymosin β4-class analytes) requiring surrogate-matrix or authentic-matrix background-subtraction approaches. * Author bioanalytical validation protocols, validation reports, study analytical plans, and the corresponding sections of regulatory submissions. ## Related Videos - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [Introduction to Responsible AI: Balancing Value and Risk](https://www.wearedevelopers.com/videos/1972-introduction-to-responsible-ai-balancing-value-and-risk) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [Building Trustworthy AI in Industry: Beyond Traditional Cybersecurity](https://www.wearedevelopers.com/videos/1948-building-trustworthy-ai-in-industry-beyond-traditional-cybersecurity) - [GenAI Security: Navigating the Unseen Iceberg](https://www.wearedevelopers.com/videos/1744-genai-security-navigating-the-unseen-iceberg) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Everything a Developer Needs to Know About MCP with Neo4j](https://www.wearedevelopers.com/magazine/604-everything-a-developer-needs-to-know-about-mcp-with-neo4j) - [What Are Large Language Models?](https://www.wearedevelopers.com/magazine/304-what-are-large-language-models) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [Best Companies to work for in London: Top 25 Companies in 2023](https://www.wearedevelopers.com/magazine/187-best-companies-to-work-for-in-london-top-25-companies-in-2023) - [Data Science & more: The Lopez dilemma](https://www.wearedevelopers.com/magazine/10-data-science-more-the-lopez-dilemma)