Lead, QC Bioassay & Biochemical - Biologics (GMP)

WuXi Biologics; Dundalk; On-site; EUR 90,000 - 120,000; Full time

Job summary

WuXi Biologics in Dundalk, Ireland seeks a QC BioAssay/Biochemical Team Lead to oversee bioassay and immunoassay testing, including in-process, release and stability analyses. You will lead cross-functional projects within the QC Bioassay/Biochemical group, align with project timelines, and drive compliant operations at a start-up facility.

The role reports to the QC Bioassay Group Lead and requires a strong background in GMP-driven QC with biologics, plus leadership experience in building and

Qualifications

• University degree in related science or quality discipline.
• 8+ years in QC with Biologics/biochemistry context advantageous.
• Experience with GMP and regulatory inspections (FDA/EMA) is beneficial.
• Strong leadership, communication and cross-functional collaboration skills.
• Knowledge of Bioassay, Immunoassay and quality control testing methods.

Responsibilities

• Lead QC Bioassay/Biochemical testing activities for in-process, release and stability testing.
• Oversee design, qualification, and validation activities for new facilities and methods.
• Coordinate with cross-functional teams to align project timelines and quality goals.
• Ensure compliance with cGMP, SOPs, and regulatory requirements in all QC activities.
• Prepare and review technical documents, reports, and deviations/CAPAs as needed.

Job description

WuXi Biologics in Dundalk, Ireland seeks a QC BioAssay/Biochemical Team Lead to oversee bioassay and immunoassay testing, including in-process, release and stability analyses. You will lead cross-functional projects within the QC Bioassay/Biochemical group, align with project timelines, and drive compliant operations at a start-up facility.

The role reports to the QC Bioassay Group Lead and requires a strong background in GMP-driven QC with biologics, plus leadership experience in building and