Bioprocess Associate, Drug Substance Production

Merck; Leinster; On-site; EUR 36,000 - 48,000; Full time

Job summary

Merck Ireland is seeking a Bioprocess Associate (Drug Substance) at Dundalk to join a fast-growing site focused on patient outcomes and safety. You will work within a cutting-edge, single-use facility and contribute to cGMP-compliant operations across DS/USP/DSP processes.

The role involves SOPs, PBRs, logbooks, OJT, and training, with a shift pattern transitioning to 4 cycle 12/7. A strong GMP background and biopharma experience are essential for success.

Qualifications

• 12+ months in a regulated GMP environment.
• Knowledge of cGMP, safety and environmental regulations in biopharma.
• Experience recording information in real-time (electronic or manual).
• Experience executing operations following SOPs, Batch Records, and Manufacturing Controls Systems.
• Experience in the biopharmaceutical industry.
• Experience working in Grade C, D and CNC environments.

Responsibilities

• Manufacture drug substance through inoculation, cell expansion, and bioreactor activities.
• Set up single-use equipment between runs and perform production per GMP and EHS principles.
• Carry out DS Downstream Processing (DSP), Upstream Processing (USP), and Buffer/Media preparation.
• Carry out production operations per SOPs and Manufacturing Batch Records (MBRs).
• Write, review, and revise SOPs, OJT's, PBRs, logbooks and training materials.
• Train and mentor colleagues in SOPs, process execution and equipment operation.
• Support KPI delivery: Safety, Quality, Schedule adherence, OEE, and training.
• Lead shift handovers and liaise with Shift Lead on production challenges.

Skills

cGMP knowledge

Regulatory compliance

Real-time data capture

SOPs & MBRs

Biopharmaceutical experience

Grade C/D/CNC cleanroom

Education

GMP training or degree

12+ months GMP environment experience

Job description

Merck Ireland is seeking a Bioprocess Associate (Drug Substance) at Dundalk to join a fast-growing site focused on patient outcomes and safety. You will work within a cutting-edge, single-use facility and contribute to cGMP-compliant operations across DS/USP/DSP processes.

The role involves SOPs, PBRs, logbooks, OJT, and training, with a shift pattern transitioning to 4 cycle 12/7. A strong GMP background and biopharma experience are essential for success.