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Alexion

Global biopharmaceuticals focusing on rare diseases

Manufacturing Shift Lead

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeAthlone, Co. Westmeath, IrelandNo salary listed

About the Job

Requirements

  • 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.
  • Ability to work independently, make sound operational decisions and escalate issues appropriately.
  • Strong written and verbal communication skills, including providing clear shift handovers and accurate documentation.
  • Experience using complex electronic systems such as process automation platforms, SAP, TrackWise or similar manufacturing systems.

Responsibilities

  • 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 escalate operational issues appropriately.
  • Deliver clear shift handovers and provide timely updates to site leadership and partner functions.
  • 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 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.
  • Act as an area lead and technical subject matter expert for upstream and downstream biologics manufacturing.
  • Anticipate, troubleshoot and escalate process or equipment issues to maintain production continuity.
  • 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.
  • 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 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 retrieving approved information, preparing event records and managing scheduled activity reminders.

Desired Qualifications

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

About the Company

Alexion

Global biopharmaceuticals focusing on rare diseases

Alexion, now the rare disease group within AstraZeneca, develops and sells therapies for rare and ultra-rare diseases by targeting the complement immune system. Its drugs, such as Soliris and Ultomiris, inhibit the C5 component to slow or stop disease processes, while Strensiq and Kanuma address specific metabolic disorders. It differentiates itself through a deep focus on complement biology, pursuing first- or best-in-class therapies, and using a strategy that blends internal R&D with acquisitions to expand its pipeline. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to a broader international market using AstraZeneca’s scale and capabilities.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1992

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