ELISA Method Development and Validation Research Technician I

Eurofins USA Clinical Trial Solutions•Lenexa, KS

2d•Onsite

About The Position

The Scientist I supports the Bioanalytical Method Development and Validation Team and manages the scientific and operational aspects of client bioanalytical projects across multiple studies. The role requires knowledge of method validation principles and the ability to communicate effectively when transferring methods to the analytical team. The position develops, validates, and transfers immunoassays and bioanalytical methods, including ADA, PK, Nab, MSD, ELISA, cell-based assays, flow cytometry, and ELISpot. With guidance, the technician plans and performs routine and non-routine projects, helps evaluate manufactured products and develop fit-for-purpose assays, and prepares technical documents for Scientific Director review. The role also compiles project data, communicates updates under direction, supports assay re-qualification, and works with internal teams and external clients. The position follows applicable regulatory requirements, procedures, customer SOPs, and site environmental health and safety requirements. It provides cross-functional support as needed and may require adjusted work hours to meet client deadlines. This is a full-time, Monday–Friday position based in the Lenexa, Kansas area, with a scheduled workday of 8:00 a.m. to 4:30 p.m. and additional hours as needed.

Requirements

Bachelor of Arts or Bachelor of Science with at least 3–4 years of method development and validation and ELISA experience; or a master's degree with at least 2–3 years; or a Ph.D. with at least 0–1 year.
Experience designing, validating, and/or performing immunoassays.
Solid ELISA experience.
Previous pharmaceutical, CRO, or clinical laboratory experience.
Ability to read, write, and interpret SOPs, technical reports, and method protocols.
Authorization to work indefinitely in the United States without restriction or sponsorship.
Ability to work in a laboratory setting and meet the physical requirements of laboratory experiments.
Ability to work additional hours as needed.

Nice To Haves

Good communication and interpersonal skills.
Proven ability to compile data and create data reports.
Proficiency with MS Word, Excel, and instrumentation software.
Ability to perform statistical analysis and interpret data.
Ability to solve practical problems and troubleshoot assays.
Ability to multitask with good time management.
Organizational skills to manage and prioritize multiple projects effectively under little supervision.
Ability to communicate effectively orally and in writing with coworkers, supervisors, and clients.
Positive attitude and genuine interest in drug discovery and development and its impact on patient health.

Responsibilities

Develop, validate, and transfer immunoassays and bioanalytical methods, including ADA, PK, Nab, MSD, ELISA, cell-based assays, flow cytometry, and ELISpot.
With guidance, design, plan, perform, and manage routine and non-routine projects.
Assist in evaluating manufactured products and developing fit-for-purpose assays.
Create validation plans, test methods, worksheets, preparation sheets, and deviation reports for review by the Scientific Director.
Compile data and collaborate with the Scientific Director on project progression.
Use IT systems such as ERP and LIMS as required.
Communicate project updates to internal teams and external clients under direction.
Work independently and as part of a team to meet client and business deadlines.
Assist with assay re-qualification as needed.
Maintain regular attendance and punctuality and perform other assigned duties.
Provide cross-functional support to other departments as needed.
Adjust work hours as needed to meet client deadlines.
Follow procedures and processes for regulated work, including applicable GxP, FDA, GLP, GDP, GCP, OECD, and CLIA requirements, and attend annual GLP training.
Comply with internal and customer SOPs.
Conduct work safely and efficiently in accordance with site environmental health and safety requirements.