Manufacturing Shift Lead - Biologics

About the role

Alexion, which develops and manufactures medicines for people living with rare and ultra-rare diseases, is building a new Bulk Drug Substance facility in Athlone, Ireland. It is looking for an experienced Manufacturing Shift Lead to run a 24/7 shift rotation, lead a team of Bioprocess Technicians and oversee manufacturing activities so that production runs safely, efficiently and in line with approved procedures, batch records and cGMP requirements.

Key responsibilities

• Lead safe, compliant and efficient shift operations, coordinate priorities and resources, and give clear handovers to site leadership and partner functions.
• Perform and oversee manufacturing activities across upstream and downstream processing areas, making shift-level decisions and escalating issues.
• Ensure activities follow SOPs, batch records, cGMP and ALCOA+ data integrity principles, and support master batch record reviews, deviations, change controls and investigations.
• Contribute to SOPs, batch records and other controlled documentation, and promote contamination control and GMP behaviour.
• Act as area lead and technical subject matter expert for upstream and downstream biologics, troubleshooting process and equipment issues.
• Use manufacturing systems such as process automation, SAP and TrackWise, and approved digital tools including AZ ChatGPT and Copilot.
• Work with Technical Services, Quality Assurance, Automation and Engineering, and coach and mentor colleagues.

Required profile

• Experience in a cGMP-regulated biologics manufacturing environment, covering both upstream and downstream processes.
• Strong knowledge of manufacturing processes and how they become SOPs and batch records.
• Working knowledge of Grade C and Grade D environments and contamination control.
• Ability to work independently, make sound operational decisions and communicate clearly, including during shift handovers.
• Bachelor's degree in a scientific discipline or equivalent relevant experience (desirable).

Required skills

• Understanding of cGMP, regulatory requirements and data integrity.
• Experience with process automation, SAP and TrackWise or similar systems.
• Lean thinking and use of digital tools responsibly.