Regulated LC-MS/MS Bioanalysis Scientist

Eurofins Clinical Trial Solutions

Lenexa (KS)

On-site

USD 90,000 - 125,000

Full time

10 days ago
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Benefits offered by this job

Excellent full-time benefits including
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Job summary

Eurofins USA Clinical Trial Solutions in Lenexa, KS, seeks a Research Scientist/Senior Scientist to advance LC‑MS/MS bioanalytical methods in a regulated CRO setting. You will develop, validate, transfer, and support analyses for diverse modalities, coordinating with QA, Operations and scientific leadership.

The role emphasizes hands-on lab work, SOP development, instrument onboarding, and process improvements, with strong emphasis on FDA/EMA/ICH M10 guidelines and teamwork.

Qualifications

  • BS, MS, or PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, or a related field.
  • 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 LC-MS/MS platforms and bioanalytical studies.
  • Strong writing and documentation skills.
  • Experience in CRO/pharma/biotech environments.
  • Knowledge of LIMS and chromatography data systems.

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 QA, Operations, PM, and Scientific Leadership.
  • Identify and implement opportunities for process improvements and efficiencies.
  • Maintain compliance with GLP, GCP, and company quality requirements.

Skills

Bioanalytical lab experience
LC‑MS/MS method development
Data analysis
Troubleshooting
Technical writing
Regulated bioanalysis
Collaboration
Process improvement

Education

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

Tools

LC‑MS/MS platforms (Waters, Sciex, Thermo, Shimadzu)
LIMS
Chromatography data systems
Laboratory informatics

Job description

Eurofins USA Clinical Trial Solutions in Lenexa, KS, seeks a Research Scientist/Senior Scientist to advance LC‑MS/MS bioanalytical methods in a regulated CRO setting. You will develop, validate, transfer, and support analyses for diverse modalities, coordinating with QA, Operations and scientific leadership.

The role emphasizes hands-on lab work, SOP development, instrument onboarding, and process improvements, with strong emphasis on FDA/EMA/ICH M10 guidelines and teamwork.

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