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Senior Associate Manufacturing (Operations Lead)

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Amgen

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Location:
Ireland , Dun Laoghaire

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

The Sr. Associate Manufacturing – Strategic Projects role offers the opportunity to collaborate with multiple functions within the Amgen Dun Laoghaire site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility. The Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEx projects and established process improvements projects. This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping. They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities. This role is primarily based on-site at Amgen Dun Laoghaire.

Job Responsibility:

  • Function as the site interface between the Product Delivery Teams (PDT’s), and ADL Manufacturing operations
  • Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection
  • Develop, review and update Production, Engineering, Operating Procedures & training materials
  • Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing
  • Evaluate, plan, and implement solutions for process improvement opportunities both current and project related
  • Support scheduling and execution of Characterisation, Engineering and PPQ runs
  • Provide troubleshooting support throughout the project and on the floor during execution of activities
  • Hold people to account for delivery and behaviours within the Manufacturing Support team and associated with the project(s)
  • Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing
  • Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects
  • Consult with Quality Assurance to ensure that GMP standards are maintained
  • Develop, review and update protocols for manufacturing activities
  • Documentation and approval of protocol deviations for manufacturing activities
  • Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes
  • Own and lead change controls as required by the Manufacturing Support team
  • Review Bills of Materials
  • Develop, review and update Product Quality Risk Assessments

Requirements:

  • Bachelor’s degree in a science discipline
  • 5+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Strong project management and organisational skills
  • Critical thinking skills
  • Negotiation and Influencing skills
  • Excellent verbal and written communication skills
  • Strong technical writing skills for GMP documentation
  • Decision Making skills and confidence to challenge others
  • Teamwork and coaching others
  • Ensures compliance within regulatory environment
  • Demonstrated ability to work independently and deliver right first-time results under minimal direction

Additional Information:

Job Posted:
April 10, 2026

Work Type:
On-site work
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