Manufacturing Shift Lead

Alexion Pharmaceuticals, Inc.; Athlone; On-site; EUR 85,000 - 110,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Athlone, Ireland is seeking a Manufacturing Shift Lead to manage a Bioprocess Technician team in a 24/7 operation. You will lead safe, compliant production activities and ensure quality and timely handovers across shifts.

The role requires strong knowledge of cGMP, SOPs, batch records and data integrity, with hands-on leadership across upstream and downstream processes. Experience with process automation and manufacturing systems is essential.

Qualifications

• Experience in a cGMP-regulated biologics manufacturing environment.
• Experience across upstream and downstream biologics manufacturing.
• Strong knowledge of SOPs, batch records and data integrity.

Responsibilities

• Lead safe, compliant and efficient shift operations against the manufacturing schedule.
• Coordinate shift priorities, allocate resources, and maintain cross-shift communication.
• Oversee and perform activities across upstream and downstream areas as needed.
• Ensure documentation, batch records and deviations are properly handled.

Skills

cGMP biologics

Upstream/downstream

Manufacturing processes

Contamination control

Data integrity

Communication

Education

Bachelor of Science

Tools

SAP

TrackWise

Process automation

Job description

Location: Athlone, Ireland Shift pattern: 24/7 shift rotation

Make a meaningful impact for patients with rare diseases

At Alexion, we develop and manufacture medicines for people living with rare and ultra-rare diseases. At our new Bulk Drug Substance facility in Athlone, we are building a manufacturing culture where safety, quality and operational excellence come first.

We are looking for an experienced Manufacturing Shift Lead to lead a team of Bioprocess Technicians and oversee manufacturing activities across our 24/7 operation.

This is a hands-on leadership role where you will help ensure that production activities are completed safely, efficiently and in accordance with approved procedures, batch records and current Good Manufacturing Practice requirements.

What you’ll do

Lead safe and effective shift operations

• Lead the safe, compliant and efficient delivery of production activities against the approved manufacturing schedule.
• Coordinate shift priorities, organise resources and maintain clear communication between shifts.
• Oversee and, where required, perform manufacturing activities across upstream and downstream processing areas.
• Make informed shift-level decisions and escal…
• Deliver clear shift handovers and provide timely updates to site leadership and partner functions.

Maintain quality and compliance

• Ensure activities are completed in accordance with SOPs, batch records, cGMP requirements and ALCOA+ data integrity principles.
• Perform and support master batch record reviews, deviation activities, change controls and event records.
• Support the investigation and resolution of operational deviations through the Quality Management System.
• Contribute to the creation, review and maintenance of SOPs, batch records and other controlled documentation.
• Promote high standards of documentation, contamination control and GMP behaviour across the shift.

Provide technical leadership

• Act as an area lead and technical subject matter expert for upstream and downstream biologics manufacturing.
• Anticipate, troubleshoot and escal…
• Use manufacturing systems, including process automation, SAP and TrackWise, to support routine operations and issue resolution.
• Work closely with Technical Services, Quality Assurance, Automation, Engineering and other partner teams.

Develop people and improve performance

• Coach and mentor colleagues, sharing process knowledge and supporting training in SOPs, process execution and equipment operation.
• Create an inclusive, collaborative shift environment where colleagues can contribute and develop.
• Lead by example in safety, quality, teamwork, productivity and continuous improvement.
• Apply Lean thinking to identify opportunities that improve safety, quality, delivery and operational performance.

Use digital tools responsibly

• Use approved electronic and automation systems accurately and in line with site procedures and data integrity requirements.
• Make appropriate use of approved digital and AI-enabled tools, including AZ ChatGPT and Copilot, to support activities such as retrieving approved information, preparing event records and managing scheduled activity reminders.

Essential Experience And Skills

You will bring:

• Experience within a cGMP-regulated biologics manufacturing environment.
• Practical experience across both upstream and downstream biologics manufacturing.
• Strong knowledge of manufacturing processes and how these are translated into controlled documents, including SOPs and batch records.
• Working knowledge of Grade C and Grade D manufacturing environments and contamination control expectations.
• Strong understanding of cGMP, regulatory requirements and data integrity principles.
• The ability to work independently, make sound operational decisions and escal…
• Strong written and verbal communication skills, including the ability to provide clear shift handovers and accurate documentation.
• Experience using complex electronic systems such as process automation platforms, SAP, TrackWise or similar manufacturing systems.

Desirable Qualifications

• A bachelor's degree in a scientific discipline, or equivalent relevant experience.

Why join us?

This is an opportunity to help shape the culture and performance of a new manufacturing facility while leading work that directly supports the supply of medicines to patients with rare diseases. You will work in a technically challenging environment, collaborate with experienced colleagues across multiple functions and play an important role in developing the capabilities of the wider manufacturing team.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.