QC Bioassay Analyst

Next Generation; Dublin; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

Next Generation in Ireland is seeking a QC Bioassay Analyst to join a leading biopharmaceutical organisation in Dublin on a 6-month contract. You will support routine laboratory testing, batch release activities, analytical investigations, and laboratory instrument qualification in a regulated environment.

The successful candidate will contribute to transfer activities, OOS investigations, data integrity and SOP upkeep, working with ELISA and cell-based bioassays.

Formación

• BSc in Biochemistry, Biotechnology, Biology, or a related scientific discipline.
• 1–2 years hands-on laboratory experience in GMP-regulated QC Bioassay or biopharmaceutical lab.
• Experience with ELISA or cell-based bioassays is advantageous.
• Strong documentation, data integrity and analytical capabilities.
• Good communication and teamwork.

Responsabilidades

• Perform routine laboratory testing and support batch release activities in accordance with established procedures.
• Execute analytical assays and accurately document laboratory results.
• Support technical transfer and co-validation activities.
• Assist with OOS investigations, data trending, and preparation of investigation reports.
• Review analytical data and identify anomalous results or trends.
• Support the preparation, review, and updating of SOPs.
• Assist with laboratory instrument qualification, calibration, and performance checks.
• Troubleshoot laboratory instrumentation and support resolution of technical issues.
• Ensure laboratory activities are completed in accordance with applicable quality and regulatory standards.

Descripción del empleo

Industry: Pharmaceutical / Biotechnology

Job Type: Contract - 6 Months

Job Overview

An exciting opportunity has arisen for a QC Bioassay Analyst to join a leading biopharmaceutical organisation in Dublin.

The successful candidate will support routine laboratory testing, batch release activities, analytical investigations, and laboratory instrument qualification within a regulated environment.

Key Responsibilities

• Perform routine laboratory testing and support batch release activities in accordance with established procedures.
• Execute analytical assays and accurately document laboratory results.
• Support technical transfer and co-validation activities.
• Assist with Out-of-Specification (OOS) investigations, data trending, and preparation of investigation reports.
• Review analytical data and identify anomalous results or trends.
• Support the preparation, review, and updating of Standard Operating Procedures (SOPs).
• Assist with laboratory instrument qualification, calibration, and performance checks.
• Troubleshoot laboratory instrumentation and support resolution of technical issues.
• Ensure laboratory activities are completed in accordance with applicable quality and regulatory standards.

Qualifications & Experience

• BSc in Biochemistry, Biotechnology, Biology, or a related scientific discipline.
• 1-2 years of hands-on laboratory experience in biological assay testing,within a GMP-regulated QC Bioassay or biopharmaceutical laboratory environment.
• Practical experience with one or more of the following analytical techniques would be advantageous:
• ELISA
• Cell-based bioassays
• Cell culture
• Understanding of laboratory testing procedures, analytical documentation, and data integrity.
• Experience supporting OOS investigations, assay troubleshooting, or laboratory instrument qualification would be beneficial.
• Ability to independently execute analytical assays and recognise unusual results or trends.
• Strong organisational, analytical, and problem-solving skills.
• Excellent communication skills and the ability to work effectively within a collaborative team environment.