Bioanalytical Method Development & Validation Specialist I

Eurofins; Lenexa (KS); Presencial; USD 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

401(k) with company match

Paid vacation

Descripción de la vacante

Eurofins USA Clinical Trial Solutions seeks a Scientist I to support the Bioanalytical Method Development and Validation Team, overseeing scientific and operational management of client bioanalytical projects. Experience with method validation and transferring methods to the analytical team is essential.

The role requires knowledge of immunoassays, ELISA, and regulatory compliance with GxP, FDA, GLP, GDP, GCP, OECD, and CLIA. Excellent communication and teamwork are required.

Formación

• B.A. or B.S. with minimum 3-4 years method development and validation & ELISA experience.
• M.A. with minimum 2-3 years method development and validation & ELISA experience.
• Ph.D. with minimum 0-1 year method development and validation & ELISA experience.

Responsabilidades

• Performs the development, validation, and transfer of immunoassays and bioanalytical methods (including ADA, PK, Nab, MSD, ELISA, cell-based, Flow Cytometry, and Elispot).
• With guidance, designs, plans, performs, and manages routine and non-routine projects.
• Assists in the evaluation of manufactured products and develops fit-for-purpose assays.
• Creates technical documents in the form of validation plans, test methods, worksheets, preparation sheets, and deviation reports.
• Compiles data and collaborates with the Scientific Director for project progression.
• Applies use of IT systems (ERP, LIMs, etc.) as required.
• Communicates project updates to internal team and external clients under direction supervision.
• Works effectively as a member of a team as well as independently to achieve client and business deadlines.
• Assists in assay re-qualification as needed.
• Demonstrates and promotes the company vision.

Conocimientos

Immunoassays

ELISA

Method validation

Transfer methods

Data reporting

Educación

B.S. degree

M.S. degree

Ph.D.

Herramientas

ERP

LIMS

MS Excel

MS Word

Descripción del empleo

Eurofins USA Clinical Trial Solutions seeks a Scientist I to support the Bioanalytical Method Development and Validation Team, overseeing scientific and operational management of client bioanalytical projects. Experience with method validation and transferring methods to the analytical team is essential.

The role requires knowledge of immunoassays, ELISA, and regulatory compliance with GxP, FDA, GLP, GDP, GCP, OECD, and CLIA. Excellent communication and teamwork are required.