Bioanalytical Method Development Scientist I

Eurofins USA Clinical Trial Solutions; Lenexa (KS); On-site; USD 70,000 - 95,000; Full time

Job summary

Eurofins USA Clinical Trial Solutions seeks a Scientist I to support Bioanalytical Method Development and Validation, overseeing scientific and operational aspects of client bioanalytical projects across multiple studies. Requires knowledge of method validation and communication to transfer methods to the analytical team.

The role develops, validates, and transfers immunoassays and bioanalytical methods (ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, Elispot), designs and manages

Qualifications

• B.A. or B.S. with 3–4 years method development and validation experience
• M.A. with 2–3 years method development and validation experience
• Ph.D. with 0–1 year method development and validation experience
• Experience in designing, validating, and/or performing immunoassays
• Pharma and/or CRO, Clinical Laboratory experience required
• Ability to read, write, and interpret SOPs, technical reports, and method protocols
• Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

• Develop, validate, and transfer immunoassays and bioanalytical methods (ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, and Elispot)
• Design, plan, perform, and manage routine and non-routine projects with guidance
• Assist in evaluating manufactured products and develop fit-for-purpose assays
• Create validation plans, test methods, worksheets, preparation sheets, and deviation reports
• Compile data and collaborate with the Scientific Director for project progression
• Apply ERP, LIMS, and other IT systems as required
• Communicate project updates to internal teams and clients under supervision
• Work as part of a team and independently to meet deadlines
• Assist in assay re-qualification as needed
• Comply with GxP, FDA, GLP, GDP, GCP, OECD, and CLIA requirements
• Maintain safety and environmental health compliance

Skills

Immunoassays

Data analysis

MS Excel

MS Word

Statistical analysis

Troubleshooting

Time management

Communication skills

Education

B.A./B.S. in relevant field

M.A. in relevant field

Ph.D. in relevant field

Tools

ERP systems

LIMS

Instrumentation software

Job description

Eurofins USA Clinical Trial Solutions seeks a Scientist I to support Bioanalytical Method Development and Validation, overseeing scientific and operational aspects of client bioanalytical projects across multiple studies. Requires knowledge of method validation and communication to transfer methods to the analytical team.

The role develops, validates, and transfers immunoassays and bioanalytical methods (ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, Elispot), designs and manages