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External Supply – Manufacturing Support - Manufacturing Process Owner

Ireland, Dun Laoghaire · Job Posted May 04, 2026
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Job Description

The External Supply - Manufacturing Support Process Owner role is a key role in the newly formed Manufacturing support team requiring in-depth technical and operational knowledge of key capabilities in our external network. The Manufacturing Support team will include a variety of roles and will report to the Associate Director of Manufacturing Support. We are currently hiring two of these roles as follows: Role 1: Aseptic DP processes; Formulation, Filling and Lyophilisation. Role 2: Capping, visual inspection and packaging. These roles will support key areas of the business; the Manufacturing Process Owner will direct initiatives that deliver execution excellence in our CDMOs, improve the reliability and efficiency of manufacturing processes in addition to day-to-day support related to unplanned event troubleshooting, investigations, CAPA identification and implementation.

Job Responsibility

  • Provide day-to-day operational oversight to ensure execution excellence via successful batch execution and on-time delivery of product
  • Lead and or support manufacturing / ops readiness
  • Supporting manufacturing in delivering supply to patients through Ownership of the assigned processes and taking a proactive approach to safety, quality and compliance
  • Subject Matter Expert with thorough in-depth knowledge of the assigned processes and interfaces
  • Monitor campaign progress and production schedules
  • Track operational performance such as yield, cycle time, and right-first-time metrics
  • Accountable point of contact for knowledge of CDMO process documentation
  • Gatekeeper of changes to CDMO process documentation
  • Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes
  • Ownership and project management of CAPAs and Change Controls at our CDMOs
  • Utilises subject matter expertise to identify and lead continuous improvement projects
  • Engaging with staff members to ensure understanding of the processes and working collaboratively cross functionally
  • Involved in the daily business management systems and reporting
  • Provide technical input to the shift teams on challenges
  • Providing expertise to Project Teams responsible for the introduction of new products and projects
  • Collaborate with process and analytical teams
  • Effectively engaging and participating within a Lean culture environment
  • Managing and implementing projects that develop lean practices in the manufacturing areas

Requirements

  • Minimally Bachelor of Science, Engineering or technical discipline
  • 5+ years of manufacturing experience in relevant Drug Substance, Drug Product Manufacturing or related cGxP manufacturing experience
  • Experience with regulatory compliance in cGxP manufacturing and in depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products

Nice to have

  • Ability to travel to sites in our CDMO network and ability to work successfully in a highly international environment
  • Problem solving skills
  • Project Management and organizational skills
  • Demonstrated ability to work independently and deliver right first-time results under minimal direction
  • Escalate issues professionally and in a timely manner
  • Negotiation and Influencing skills
  • Take initiative to identify and drive improvements using lean six sigma tools
  • Excellent verbal and written communication skills
  • Strong Technical writing skills for cGxP documentation
  • good Presentation skills
  • Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area
  • Teamwork and ability to coach, mentor and/or cross train colleagues within core technical areas
  • Ensures compliance within regulatory environment
  • Familiar with data analytics
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