ELISA Method Development and Validation Research Technician I

Eurofins•Lenexa, KS

2h•Onsite

About The Position

The ELISA Method Development and Validation 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 transfer methods 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 performs routine and non-routine projects, helps evaluate manufactured products, develops fit-for-purpose assays, compiles data, and assists with project progression and assay re-qualification. The position also involves preparing technical documents for review by the Scientific Director, using applicable IT systems, and communicating project updates to internal teams and external clients under direction. The role requires compliance with applicable regulatory procedures and customer and internal SOPs, including annual GLP training, and adherence to site environmental health and safety requirements. The technician works both independently and as part of a team, provides cross-functional support, maintains regular attendance, and adjusts work hours as needed to meet client deadlines. The position is full-time, Monday through Friday, 8:00 a.m. to 4:30 p.m., with additional hours as needed, and is based within commuting distance of Lenexa, Kansas.

Requirements

Bachelor of Arts or Bachelor of Science with at least 3–4 years of method development and validation and ELISA experience; or Master of Arts with at least 2–3 years; or 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.
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 develop fit-for-purpose assays.
Create validation plans, test methods, worksheets, preparation sheets, and deviation reports for Scientific Director review.
Compile data and collaborate with the Scientific Director on project progression.
Use IT systems, including ERP and LIMS, as required.
Communicate project updates to internal teams and external clients under direction.
Work effectively independently and as a team member to meet client and business deadlines.
Assist with assay re-qualification as needed.
Demonstrate and promote the company vision.
Maintain regular attendance and punctuality.
Perform other duties as assigned and provide cross-functional support to other departments as needed.
Adjust work hours as needed to meet client deadlines.
Follow procedures and processes required for regulatory compliance, including GxP, FDA, GLP, GDP, GCP, OECD, and CLIA, and attend annual GLP training.
Comply with internal and customer SOPs.
Conduct activities safely and efficiently in accordance with site EHS requirements.