Senior LC-MS/MS Bioanalysis Scientist

Eurofins USA Clinical Trial Solutions; Lenexa (KS); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Clinical Trial Solutions is seeking a Research Scientist/Senior Scientist to advance LC-MS/MS bioanalytical capabilities within a regulated CRO setting. You will develop, validate, transfer, and support analyses for diverse modalities including small molecules, peptides, ADCs, and mAbs.

The ideal candidate brings hands-on LC-MS/MS method development/validation experience and knowledge of FDA/EMA/ICH M10 guidance, contributing to SOPs and process improvements in a collaborative team.

Qualifications

• BS, MS, or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
• 3–8+ years of relevant bioanalytical laboratory experience.
• Hands-on experience with LC-MS/MS method development and validation.
• Working knowledge of FDA, EMA, and ICH M10 bioanalytical method validation requirements.
• Experience with small molecules, peptides, oligonucleotides, ADCs, or mAbs.
• Experience supporting regulated bioanalytical studies and routine sample analysis.
• Strong technical writing and documentation skills.
• Experience in a CRO, pharmaceutical, or biotechnology environment.
• Familiarity with hybrid LC‑MS/LBA approaches.
• Experience with laboratory informatics systems, including LIMS and chromatography data systems.
• Knowledge of assay validation, sample management, and regulated study workflows.

Responsibilities

• Develop, optimize, qualify, and validate LC-MS/MS bioanalytical methods for regulated studies.
• Perform sample preparation, instrument operation, data analysis, and troubleshooting.
• Support routine sample analysis for preclinical and clinical studies.
• Assist with assay validation activities in accordance with FDA, EMA, and ICH M10 guidance.
• Analyze and interpret data and contribute to study reports and technical documentation.
• Author and revise SOPs, work instructions, validation protocols, and technical reports.
• Support onboarding, qualification, and maintenance of LC-MS/MS instrumentation and associated laboratory systems.
• Collaborate with cross-functional teams including Quality Assurance, Operations, Project Management, and Scientific Leadership.
• Identify and implement opportunities for process improvements and operational efficiencies.
• Maintain compliance with applicable GLP, GCP, and company quality requirements.

Skills

LC-MS/MS method development

Bioanalytical method validation

Regulated bioanalysis

Data analysis

Technical writing

SOP development

LIMS

LC-MS/MS platforms

Education

Analytical Chemistry / Biochemistry / Pharmaceutical Sciences (BS/MS/PhD)

Tools

Waters LC-MS/MS

Sciex LC-MS/MS

Thermo Fisher LC-MS/MS

Shimadzu LC-MS/MS

Job description

Eurofins USA Clinical Trial Solutions is seeking a Research Scientist/Senior Scientist to advance LC-MS/MS bioanalytical capabilities within a regulated CRO setting. You will develop, validate, transfer, and support analyses for diverse modalities including small molecules, peptides, ADCs, and mAbs.

The ideal candidate brings hands-on LC-MS/MS method development/validation experience and knowledge of FDA/EMA/ICH M10 guidance, contributing to SOPs and process improvements in a collaborative team.