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.