Method Development and Validation Research Technician I

Eurofins USA Clinical Trial Solutions•Lenexa, KS

7d•Onsite

About The Position

The Research Technician I supports the Bioanalytical Method Development and Validation Team and contributes to the scientific and operational management of client bioanalytical projects across multiple studies. The role requires knowledge of method-validation principles and communication skills to support method transfer to the analytical team. The technician 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 carries out routine and non-routine projects, helps evaluate manufactured products, develops fit-for-purpose assays, prepares technical documents, compiles data, and supports project progression in collaboration with the Scientific Director. The role also includes communicating project updates, supporting assay re-qualification, using relevant IT systems, and providing cross-functional support. The position requires compliance with applicable regulatory requirements and procedures, including GxP, FDA, GLP, GDP, GCP, OECD, and CLIA requirements, as well as internal and customer SOPs. The technician must follow site environmental health and safety requirements, maintain regular attendance, and adjust work hours as needed to meet client deadlines. This is a full-time position, Monday through Friday, 8:00 a.m. to 4:30 p.m., with additional hours as needed. The posting encourages applicants who live within commuting distance of Lenexa, Kansas, and lists a work location in St. Charles, Missouri.

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 of Arts 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 and/or 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.

Nice To Haves

Good communication and interpersonal skills.
Ability to compile data and create data reports.
Computer 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 and manage time effectively.
Organizational skills to manage and prioritize multiple projects with 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 team members and external clients under direction and supervision.
Work independently and as part of a team to meet client and business deadlines.
Assist with assay re-qualification as needed.
Promote the company vision, maintain regular attendance and punctuality, and perform other duties as assigned.
Provide cross-functional support to other departments as needed.
Adjust work hours as needed to meet client deadlines.
Follow applicable regulatory requirements and work procedures, attend annual GLP training, and comply with internal and customer SOPs.
Conduct activities safely and efficiently in accordance with site environmental health and safety requirements.