Senior Bioanalytical Scientist (LC-MS/MS) - Regulated CRO

Eurofins; Lenexa (KS); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins USA Clinical Trial Solutions in Lenexa, KS seeks a Research Scientist / Senior Scientist to advance regulated bioanalytical LC-MS/MS capabilities within a CRO setting. You will contribute to method development, validation, transfer, and support sample analysis across small molecules, peptides, oligos, ADCs, and mAbs.

The role partners with QA, Operations, Project Management and Scientific Leadership to implement assays in compliance with FDA, EMA and ICH M10, while helping develop SOPs

Qualifications

• Experience developing and validating LC-MS/MS methods for regulated studies.
• Familiarity with FDA, EMA and ICH M10 bioanalytical requirements.
• Experience with regulated bioanalytical studies and routine sample analysis.

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 related systems.
• Collaborate with QA, Operations, Project Management, and Scientific Leadership.
• Identify opportunities for process improvements and operational efficiencies.
• Maintain compliance with GLP, GCP, and quality requirements.

Skills

Analytical Chemistry

Bioanalytical expertise

Data analysis

Technical writing

Troubleshooting

Cross-functional collaboration

Regulatory knowledge

Education

BS/MS/PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry

Tools

LC-MS/MS

LIMS

Chromatography data systems

Job description

Eurofins USA Clinical Trial Solutions in Lenexa, KS seeks a Research Scientist / Senior Scientist to advance regulated bioanalytical LC-MS/MS capabilities within a CRO setting. You will contribute to method development, validation, transfer, and support sample analysis across small molecules, peptides, oligos, ADCs, and mAbs.

The role partners with QA, Operations, Project Management and Scientific Leadership to implement assays in compliance with FDA, EMA and ICH M10, while helping develop SOPs