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External Supply - Manufacturing Support - Associate Director

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Amgen

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Location:
Ireland , Dun Laoghaire

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The External Supply Associate Director of Manufacturing support will report directly to the Executive Director Manufacturing for External Supply and will join the ACDM (Amgen Contract Development and Manufacturing) leadership team. They will apply their extensive leadership experience to establish, build and advance a newly established and centralized organization which will ultimately have responsibility for manufacturing support of all Drug Substance, Drug Product, Inspected Drug Product and Finished Drug Product manufacturing operations in External Supply. This centralized organization will be composed of Process Owners (specialised in capabilities including aseptic filling operations, visual inspection and peptide manufacturing) who will apply their technical depth & expertise to drive execution excellence in a consistent manner across our network of external sites.

Job Responsibility:

  • Serving on the ACDM leadership team
  • Providing leadership to the organization that provides manufacturing support to identify and resolve manufacturing, process and system issues associated with external manufacturing operations
  • Developing and implementing a departmental strategy which aligns with the broader organizational strategy
  • Ensuring external manufacturing associated metrics and measures meet requirements
  • Delivering on headcount, productivity and budget targets
  • Effectively collaborate with key customers and support groups in External Supply and across the Amgen Network to ensure best practices are applied to assigned CMOs
  • Build, develop and retain a diverse and high performing team
  • Responsible for product lifecycle management and associated electronic batch records as well as for the support of new product introductions and capital projects being implemented into manufacturing within CMOs
  • Responsible for the Process Owner organization which provides process support for all external manufacturing areas, including support for process improvement and aseptic compliance and supporting manufacturing in delivering supply to patients
  • Driving improvements to the investigation process, right first-time investigation reports and records
  • Leading manufacturing support related activities for ensuring major deviations are robust, comprehensive and compliant as per procedures and that deviation closure timelines meet requirements to enable supply of product to our Patients
  • Lead and support regulatory inspections for manufacturing-support related activities
  • Driving continuous improvements to business processes within external manufacturing.

Requirements:

  • 8+ years of experience in pharmaceutical Manufacturing positions
  • 4+ years management experience
  • Bachelor's Degree or combination of education and/or years of experience
  • Master's degree and 6 years of Manufacturing / Operations experience OR Bachelor's degree and 8 years of Manufacturing / Operations experience OR Leadership Experience of directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Nice to have:

  • Degree in Biology, Chemistry, or Engineering
  • Experience with cGMP Production environments and an understanding of its regulatory requirements
  • Proven leadership and demonstration of process continuous improvement
  • Experience with deviation investigations and CAPAs
  • Demonstrated ability with project management (principles and techniques), initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development
  • Experience participating in, managing, and responding to corporate audits/regulatory inspections
  • Ability to clearly communicate status of the investigation to leadership and to auditors and inspectors
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Analysis of complex problems and delivery of clear and timely feedback
  • Strong interpersonal skills.

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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