Manufacturing Shift Lead

Alexion Pharmaceuticals, Inc.; Athlone; On-site; EUR 70,000 - 95,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Athlone is seeking a Manufacturing Shift Lead to direct production activities in a 24x7 aseptic facility, develop colleagues, and ensure medicines are delivered safely and on time.

You will oversee GMP-compliant tasks, mentor the team, drive continuous improvement, and collaborate with QA, Engineering and Technical Services while using SAP and TrackWise for documentation and data integrity.

Qualifications

• Experience in a cGMP aseptic manufacturing environment is required.
• Knowledge of vial and syringe filling processes and related equipment.
• Proficiency with controlled documentation such as SOPs and batch records.
• Ability to make sound operational decisions and escalate when needed.
• Strong communication across manufacturing, quality and technical teams.
• Experience with SAP, TrackWise or similar digital systems.

Responsibilities

• Coordinate and guide safe, compliant production execution per schedule and patient supply needs.
• Lead core production tasks across Formulation, Compounding, Filling, Inspection and related activities.
• Direct local shift activities, set priorities and maintain clear cross-shift communication.
• Oversee GMP, quality documentation, batch records and deviation handling as required.
• Mentor colleagues, support training, and promote EHS and continuous improvement.

Skills

Aseptic manufacturing

Vial & syringe filling

SOPs & batch records

Operational decision making

Team communication

SAP & TrackWise

Education

BA/BS in science

Tools

Process automation

Job description

Reports to: Operations Supervisor, Drug Product Operations

Location: Monksland, Athlone

Contract: Permanent Contract

Shift: 4 Cycle, 12.25 hr. Shift, 41.1 hr. Average Work Week (24x7 Operations)

Introduction To Role

At Alexion, AstraZeneca Rare Disease, every role contributes to delivering life-changing medicines for people living with rare and ultra-rare diseases. As a Manufacturing Shift Lead, you will play a key role in leading production activities, developing colleagues, and helping ensure patients receive high-quality medicines safely and on time.

Working within our state-of-the-art aseptic manufacturing facility in Athlone, you'll combine technical expertise, leadership and collaboration to support a culture of operational excellence, continuous improvement and patient focus.

This role offers the opportunity to develop your technical expertise, leadership capability and cross-functional collaboration skills within one of AstraZeneca's most advanced manufacturing environments. You'll work alongside experts across Operations, Quality, Engineering and Technical Services while contributing directly to the delivery of medicines for patients around the world.

Accountabilities

Shift Leadership and Schedule Execution

• Coordinate and guide safe, compliant and efficient execution of production activities in line with the approved schedule, local priorities and patient supply requirements.
• Independently perform and oversee core production tasks across areas such as Formulation, Compounding, Pooling, Washing, Autoclaving, Sterilisation, Aseptic Filling, Visual Inspection and ancillary equipment preparation activities, where applicable.
• Coordinate local shift activities, identify priorities, organise work teams effectively and maintain clear communication between shifts.

GMP, Quality and Documentation

• Complete all tasks in accordance with approved SOPs, batch records and cGMP requirements, ensuring strong attention to detail and excellent documentation practices aligned with ALCOA+ principles.
• Perform and support MBR reviews, EQV deviation activities, change controls and event records as required.
• Assist with the investigation of operational deviations through the QMS, engaging relevant personnel and functions to ensure timely, robust and compliant resolution.
• Provide input to the creation, review and maintenance of area SOPs, batch records and other controlled documentation.

Technical Leadership and Troubleshooting

• Act as an area lead and technical subject matter expert, providing visible leadership, guidance and support to Operations Technical SMEs and shift colleagues.
• Demonstrate a high level of SME knowledge and experience in Line 2 operations, including the ability to anticipate, troubleshoot and escalating operational issues appropriately.
• Interface effectively with MCS and other manufacturing systems to support issue resolution, process control and routine production execution.
• Engage effectively with Technical Services, Quality Assurance, Automation, Engineering and other partners to resolve issues and maintain production continuity.

People Development and Continuous Improvement

• Mentor and coach colleagues by sharing process knowledge, supporting training in SOPs, process execution and equipment operation, and helping build capability across the shift team.
• Act as a positive role model for EHS, GMP behaviours, productivity, teamwork and continuous improvement.
• Prepare and deliver effective shift handovers and provide clear updates to DP Leadership, Technical Services and Engineering as required.
• Champion continuous improvement initiatives that enhance quality, delivery and productivity.

Digital Systems and AI-Enabled Support

• Use approved electronic systems, including process automation, SAP and TrackWise, accurately and in accordance with site procedures and data integrity expectations.
• Use approved digital tools, including AZ ChatGPT and Copilot, to access procedures, support documentation activities, retrieve relevant process information and improve day-to-day operational effectiveness in line with site procedures and data integrity requirements.

Essential Skills/Experience

• Experience working in a cGMP aseptic manufacturing environment.
• Knowledge of vial and syringe filling operations and associated manufacturing processes.
• Experience using controlled documentation such as SOPs and batch records.
• Confidence in making operational decisions, solving problems and escalating issues when needed.
• Strong communication skills with the ability to build effective relationships across manufacturing, quality and technical teams.
• Experience working with electronic manufacturing and quality systems such as SAP, TrackWise and process automation platforms.

Desirable Skills/Experience

• BA/BS in a scientific subject area or equivalent experience preferred.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why this essential worker role works full time onsite. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives. Our patient-driven culture encourages exploration of new ideas that have a profound impact on lives. Diversity is valued here, fostering an inclusive atmosphere where life-changing ideas can emerge from anywhere. We celebrate achievements together, ensuring kindness is integral to our ambition to succeed for those in need. Our commitment extends beyond our work, as we take pride in giving back to the communities we serve.

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.