ELISA Method Development and Validation Research Scientist I

Eurofins USA Clinical Trial Solutions•Lenexa, KS

About The Position

The Scientist I supports the Bioanalytical Method Development and Validation Team and manages the scientific and operational aspects of multiple client bioanalytical projects. The role requires knowledge of method validation principles and the communication skills needed to transfer methods to the analytical team. The Scientist performs the development, validation, and transfer of immunoassays and bioanalytical methods, including ADA, PK, Nab, MSD, ELISA, cell-based assays, Flow Cytometry, and Elispot. With guidance, the Scientist designs, plans, performs, and manages routine and non-routine projects; assists in evaluating manufactured products and developing fit-for-purpose assays; and prepares technical documents for review by the Scientific Director. The role also involves compiling data, supporting project progression, communicating updates to internal teams and clients under direction, and assisting with assay re-qualification. The Scientist works independently and as part of a team to meet client and business deadlines, provides cross-functional support, and adjusts work hours as needed to meet client deadlines. The position requires compliance with applicable regulatory requirements and procedures, including GxP, FDA, GLP, GDP, GCP, OECD, and CLIA, as well as internal and customer SOPs. The employee attends annual GLP training and follows site environmental health and safety requirements. The position is full-time, Monday through Friday, 8:00 a.m. to 4:30 p.m., with additional hours as needed. Candidates within commuting distance of Lenexa, Kansas are encouraged to apply.

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 documents such as 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 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 a team member to meet client and business deadlines.
Assist with assay re-qualification as needed.
Provide cross-functional support to other departments as needed.
Adjust work hours as needed to meet client deadlines.
Follow applicable regulatory procedures, internal and customer SOPs, and site environmental health and safety requirements; attend annual GLP training.
Maintain regular attendance and punctuality, demonstrate and promote the company vision, and perform other duties as assigned.