Method Development and Validation Research Technician I

The Scientist I will support the Bioanalytical Method Development and Validation Team and is responsible for the overall scientific and operational management of client bioanalytical projects supporting a variety of studies simultaneously.

This role requires knowledge of method validation principles and communication skills required to transfer methods to the analytical team.

Research Technician I Duties Include but are not Limited to the Following:

• Performs the development, validation, and transfer of immunoassays and bioanalytical methods (including but not limited to 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 for review by the Scientific Director.

• 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.

• Maintains regular attendance and punctuality.

• Performs other duties as assigned.

• Provides cross-functional support to other departments as needed.

• Adjusts work hours as needed to meet client deadlines.

• Understands and follows all procedures and processes required for work performed under Regulatory Compliance (e.g., GxP, FDA, GLP, GDP, GCP, OECD, and CLIA) and attends annual GLP training.

• Complies with internal and customer SOP’s as required.

• Conducts all activities in a safe and efficient manner by adhering to site environmental health and safety (EHS) requirements.