JobMesh

Temp QC Technical Resources Specialist

Regeneron · Limerick, Munster, IE

Within this role you will s upport lifecycle management within the QC Technical Resources group. You will participate (Perform, Review, Co-ordinate) in assay...

Job description

Within this role you will s upport lifecycle management within the QC Technical Resources group. You will participate (Perform, Review, Co-ordinate) in assay development, characterization, optimization, transfer, validation and investigation for QC group. You may provide technical support, guidance and supervision for release, stability, and in-process testing and assay development as a subject matter expert (SME). Please note this is a 12-month contract position. As a Temp QC Technical Resources Specialist , a typical day might include, but is not limited to, the following: - Collaborating with Analytical Sciences (AS) to integrate methods into QC Commercial evaluating and selecting suitable methods prior to process validation - Monitoring and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed - Liaising with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management - Monitoring method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites - Coordinating post-...