QC Bioassay Scientist — GMP & Cell Culture Expert

WuXi Biologics; Dundalk; On-site; EUR 52,000 - 76,000; Full time

Job summary

WuXi Biologics in Dundalk, Ireland, is seeking a QC Bioassay/Biochemical Assay Scientist to join the Bioassay/ Biochemical Assay Laboratories with emphasis on one area. You will support GMP testing, validation, and routine QC work across multiple assay types such as cell-based bioassays, ELISA, and qPCR.

The role requires a Third Level BSc in related science/quality discipline, hands-on GMP QC experience, aseptic technique, and potential cell culture work.

Qualifications

• Third level BSc degree in related science/quality discipline.
• Experience in a Quality Control / GMP environment.
• Experience with aseptic techniques and operation of a Biosafety Cabinet (BSC).
• Cell culture experience desirable.
• Experience with Bioassay/ Immunoassay/ Enzyme activity methods desirable.
• Knowledge of FDA/EMEA regulatory requirements applicable to biologics/pharmaceuticals; ICH and GMP guidelines desirable.
• Knowledge of routine and non-routine QC testing and techniques and related equipment.
• Biosafety requirements including EPA containment guidelines for GM cell lines.

Responsibilities

• Perform analytical method transfer, validation and GMP routine analysis (Cell Based Bioassays, Chromogenic Assays, Enzyme Activity, ELISA, qPCR, Western Blot).
• Perform cell culture techniques including cell banking, revivals, and routine passaging of adherent and suspension lines.
• Support QC team strategy and cross-functional collaboration in Dundalk.
• Ensure GMP documentation and release testing support for Drug Substance.
• Contribute to risk assessments (Quality and EHS) and CAPAs and change controls.
• Develop training material for QC Bioassay/Biochemistry Laboratory personnel and act as a trainer.
• Lab scheduling and KPI monitoring; support audits and regulatory inspections.

Skills

Communication

Problem solving

Team collaboration

Autonomy

Adaptability

Education

BSc in related science/quality discipline

Tools

Aseptic techniques

BSC operation

Cell culture

qPCR

Job description

WuXi Biologics in Dundalk, Ireland, is seeking a QC Bioassay/Biochemical Assay Scientist to join the Bioassay/ Biochemical Assay Laboratories with emphasis on one area. You will support GMP testing, validation, and routine QC work across multiple assay types such as cell-based bioassays, ELISA, and qPCR.

The role requires a Third Level BSc in related science/quality discipline, hands-on GMP QC experience, aseptic technique, and potential cell culture work.