Senior Manufacturing Biotech Associate

About the role

An opportunity has arisen for a Senior Manufacturing Biotech Associate at MSD's single-use Dunboyne facility. You will join a self-directed work team in Solution Prep Operations, responsible for all procedures and processes associated with the manufacture of Drug Substance. The role is site-based and requires 24/5 shift work including days, nights and rotation.

Key responsibilities

• Act as a senior team member with strong technical knowledge of processes and procedures, and become an SME in Downstream processes
• Train, coach and mentor less experienced team members, and collaborate proactively in a matrix reporting environment
• Organise and lead local work teams, and help deliver business unit goals through collaboration with other departments
• Seek the production schedule daily, plan to achieve or exceed it, and take part in shift handovers and Tier meetings
• Take part in inspections, GEMBA, Go-See, OPPS, improvement projects and other MPS initiatives
• Perform EBR and documentation reviews, QN investigations and closure, and other documentation or administrative tasks
• Use Lean Six Sigma tools for continuous improvement
• Represent the department at meetings and discussions when deputised

Required profile

• A Level 7 or higher qualification in a science or engineering discipline, with at least 3 years' experience in a GMP-regulated manufacturing environment
• Strong experience in a highly regulated pharmaceutical manufacturing environment
• Detailed overview of Upstream and Downstream processes, with particular expertise in Downstream manufacturing
• Working knowledge of process equipment and of manufacturing GMP and quality systems
• Ability to work with multiple stakeholders across departments and to manage multiple priorities

Required skills

• Proficiency with production systems such as MES, DeltaV, SAP and GLIMS
• Knowledge of Kanban, JIT, 5S and Lean Manufacturing
• Troubleshooting, problem-solving and coaching abilities