Operations Lead Biotech Associate – Cell Banking

About the role

Merck KGaA (MSD) is looking for an Operations Lead Biotech Associate for its Cell Banking and cell expansion team at the Dunboyne, Co. Meath site, which manufactures biologics drug substance for clinical supply, registration and commercial launch. The role covers end-to-end production operations within a specific manufacturing IPT, acting as a delegate for the shift lead when unavailable and ensuring GMP compliance.

Key responsibilities

• Support end-to-end production operations and run shift standard work through a team-based approach to batch progression
• Execute processes according to work instructions and SOPs, and run handover boards for shift leads
• Act as escalation point for troubleshooting, problem solving and continuous improvement projects, escalating unresolved issues to the shift manager or operations lead
• Ensure activities are done right first time, with accurate electronic batch record reviews and real-time batch record, SAP Comet and elogs checks by the end of each shift
• Author, review and edit procedures and technical documents under cGMP, and coach teams on RFT documentation
• Maintain high safety and GMP standards, promote EHS leadership, and take part in safety walkdowns, audits, inspections, risk assessments and incident investigations
• Coach on CAPAs, change actions, SOP updates and training modules, and lead approved projects and continuous improvement initiatives using real-time data analytics
• Work in a multi-disciplined process team, support colleagues as requested, and carry out other duties assigned by the Manager

Required profile

• Bachelor's degree in biotechnology, chemistry, biology, pharmacy or process engineering
• 5+ years of experience in the biotech industry, including bulk manufacturing of pharmaceutical or biological components
• Familiarity with contamination control and batch release requirements
• Experience with single-use technologies in a manufacturing environment
• Competence in troubleshooting and practical problem solving, able to work independently and in a cross-functional team

Required skills

• Proficiency with Delta V, Pas X and automation in manufacturing
• Good Manufacturing Practices (GMP)
• Autoclaving, media preparation, liquid chromatography (LC) and cell culture process development

The role is site-based, with 12/7 extended days (4 days on, 4 days off), and requires no relocation, visa sponsorship or travel.