Method Development and Validation Research Technician I

Eurofins•Lenexa, KS

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 includes developing, validating, and transferring immunoassays and bioanalytical methods, preparing technical documentation, compiling data, communicating project updates, and supporting assay re-qualification. Work is performed under applicable regulatory requirements, internal and customer procedures, and site environmental health and safety requirements. The position may require adjusted work hours to meet client deadlines and cross-functional support for other departments.

Requirements

B.A. or B.S. and at least 3–4 years of method development and validation and ELISA experience; or M.A. and at least 2–3 years of such experience; or Ph.D. and at least 0–1 year of such experience.
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 documents such as SOPs, technical reports, and method protocols.
Authorization to work in the United States indefinitely 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 in 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 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 develop fit-for-purpose assays.
Prepare 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, including ERP and LIMS, as required.
Communicate project updates to internal teams and external clients under direct supervision.
Work effectively both as a team member and independently to meet client and business deadlines.
Assist with assay re-qualification as needed.
Demonstrate and promote the company vision; 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 activities safely and efficiently by adhering to site EHS requirements.