Bioprocess Associate – Drug Substance (Day Shift)

Merck Gruppe - MSD Sharp & Dohme; Leinster; Hybrid; EUR 47,000 - 65,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

Merck Group - MSD Sharp & Dohme in Ireland seeks a Bioprocess Associate (Drug Substance) at our Dundalk facility, to manufacture drug substance using DS DSP/USP in a state-of-the-art single-use facility.

You will work with GMP and EHS standards, lead SOPs and training, support KPI delivery, and participate in shift handovers; the role is currently days with a transition to 4 cycle 12/7, and offers hybrid working where possible.

Qualifications

• 12+ months in a regulated GMP environment.
• Knowledge of cGMP, safety and environmental regulations in biopharmaceuticals.
• Experience recording information in real-time (electronic or manual).
• Experience executing operations following SOPs, Batch Records and Manufacturing Controls.

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 prep.
• Follow SOPs, Batch Records, and Manufacturing Controls Systems in all operations.
• Assist in maintaining a safety-oriented, cGMP-compliant environment.
• Write, review, and revise SOPs, OJT, PBRs, logbooks and Work Instructions.
• Train and mentor colleagues in SOPs and equipment operation.
• Support KPIs: safety, quality, schedule adherence, OEE, and team training.
• Assist investigations and deviations via Quality System and engage relevant stakeholders.
• Lead and participate in shift handovers and liaise with Shift Lead on issues.
• Apply Lean tools (5S, TPM, Gemba) to improve efficiency and CI culture.
• Provide cross-functional support to maintenance, engineering, quality as needed.
• Operate in accordance with company policies & SOPs and global regulatory guidelines.
• Support development, commissioning and qualification of new vaccine drug substance manufacturing equipment.

Skills

Analytical Problem Solving

Biological Manufacturing

Cleanroom Gowning

Computer Literacy

GMP Operations

Good Manufacturing Practices (GMP)

Manufacturing Quality Control

Standard Operating Procedure (SOP)

Upstream Processing

Vaccine Production

Education

Regulated GMP environment experience

Job description

Merck Group - MSD Sharp & Dohme in Ireland seeks a Bioprocess Associate (Drug Substance) at our Dundalk facility, to manufacture drug substance using DS DSP/USP in a state-of-the-art single-use facility.

You will work with GMP and EHS standards, lead SOPs and training, support KPI delivery, and participate in shift handovers; the role is currently days with a transition to 4 cycle 12/7, and offers hybrid working where possible.