Senior Scientist, QC Separations (Biologics)

WuXi Biologics

Dundalk

On-site

EUR 90,000 - 120,000

Full time

44 hours ago

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Job summary

WuXi Biologics in Dundalk is seeking a QC Separations Senior Scientist to lead a range of technical projects in the QC Seprations group. You will support the start-up and qualification of a new facility for drug substance production, while ensuring compliance with cGMP and QA standards.

The role requires extensive QC experience in Biologics, with hands-on expertise in HPLC, CE, cIEF, and related methods. You will mentor Scientists and Associate Scientists and collaborate with cross-functional

Qualifications

6+ years experience in Quality Control environment.
Biologics industry experience is essential.
Familiar with FDA/EMA regulatory requirements and GMP guidelines.
Experience with tech transfer, validation, and troubleshooting QC methods.
Supervisory experience with coaching and scheduling.

Responsibilities

Lead QC separations projects and support startup, commissioning, and qualification activities.
Support design, construction, and commissioning of the new Biologics QC facility.
Provide technical guidance, coaching, and training for Scientists and Associate Scientists.
Perform analytical method transfer, verification/validation, and routine analysis (HPLC/CE/cIEF, etc).
Maintain cGMP compliance and support risk assessments and change controls.
Collaborate with QC and other departments to support startup operations.