This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the Biopharmaceutical and related industry sectors from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally. Recently, this business has announced expansions into geographies such as the U.S and most recently Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site which once built, will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bioprocessing, a next-generation manufacturing technology which will be implemented for the first time at this site and once complete will employ in the region of 400 staff. With this expansion, an exciting opportunity has arisen for a Biologics Process Technical Lead (Associate Director) to join the organisation at the start-up phase in leading this business through construction and into manufacturing.

The Role

• The Process Technical Lead will provide technical expertise to the manufacturing shift team in support of the commercial scale manufacturing of monoclonal antibiodies.
• You will ensure on-going optimization of the process and provide manufacturing support to ensure the continued manufacture and supply of quality biologic products in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
• As a Process Technical Lead, you will work with the manufacturing shift team to ensure the effective and efficient on-time delivery of batch production. This requires the delivery of process excellence and reliability across all areas of the manufacturing process.
• Reporting to the Manufacturing Lead for the site, the Process Technical Lead will support operational readiness during start-up and provide operations input to ensure the facility design meets end user requirements. Post start-up, the Technical Lead will support the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, right first-time execution, compliance and team training.

The Person

• Third level qualification in a Science or Engineering related subject.
• A minimum of 5 years' experience in a large-scale biologics manufacturing facility.
• Thorough knowledge of current Good Manufacturing Practices (cGMP).
• Previous experience in a highly regulated manufacturing environment in a technical or manufacturing support role.
• In-depth working knowledge of manufacturing operations.

To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.