Method Development and Validation Research Technician I

Eurofins USA Clinical Trial Solutions•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 multiple client bioanalytical projects. The role involves developing, validating, and transferring immunoassays and other bioanalytical methods, and requires knowledge of method validation principles and the ability to communicate method transfers to the analytical team. With guidance, the technician plans and performs routine and non-routine projects, helps evaluate manufactured products, and develops fit-for-purpose assays. The position also involves preparing technical documents, compiling and interpreting data, communicating project updates, assisting with assay re-qualification, and applying relevant IT systems. The technician works independently and as part of a team to meet client and business deadlines, follows applicable regulatory requirements and SOPs, attends annual GLP training, and adheres to site environmental health and safety requirements. Work hours may be adjusted as needed to meet client deadlines.

Requirements

Bachelor’s degree with a minimum of 3–4 years of method development and validation and ELISA experience; or master’s degree with 2–3 years; or Ph.D. with 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.

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.
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, including ERP and LIMS, as required.
Communicate project updates to internal teams and external clients under direction and supervision.
Work effectively independently and as part of a team 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 applicable to regulatory compliance, including 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.