Director Manufacturing

Director Manufacturing

Amgen

Dublin, Ireland

OVERVIEW:

This role will report to the Executive Director of Manufacturing and will be responsible for overseeing the end-to-end drug product manufacturing of syringe products at the Amgen Dun Laoghaire Site. The successful candidate will have the following primary responsibilities:

  • Operating the areas in a safe and compliant manner ensuring the highest of standards and performance
  • Manufacturing syringe products according to the required supply plans
  • Driving a program of LEAN continuous improvement to increase productivity
  • Supporting the development and implementation of a multi-year strategic plan for New Product Introduction and Product Life Cycle Management
  • Developing the organisation through ensuring effective talent management and succession planning

KEY RESPONSIBILITIES:

Operate the areas in a safe and compliant manner ensuring the highest of standards

  • Maintain and continuously improve the manufacturing area’s strong safety, quality, and compliance culture
  • Implement effective programs to improve reliability, reduce errors, and to eliminate non-conformances
  • Prepare for and lead manufacturing aspects of regulatory inspections

Manufacture syringe products according to the required supply plan

  • Operate the plant to enable delivery of short and long-term supply requirements
  • Implement and champion an effective multi-layered management system to ensure effective communication, escalation, and delivery of the supply plan
  • Ensure appropriate oversight and management of critical manufacturing activities and ensure timely resolution of manufacturing flow interrupters and issues

Drive a program of LEAN continuous improvement to increase productivity

  • Develop a culture of continuous improvement and focus on productivity
  • Identify and implement a multi-year program to deliver productivity goals
  • Develop and manage the functional budget. Integrate annual productivity savings based on projects identified in advance (minimum 4% productivity per year)

Develop and implement a multi-year strategic plan for manufacturing

  • Identify manufacturing capabilities required to support the long range plan and work with Process Development, Engineering and Capital Projects to integrate into site master plan
  • Integrate large scale continuous improvement initiatives into the strategic plan
  • Deliver on key productivity measures such as OEE, turnaround, throughput and yield

New Product Introduction and Product Life Cycle Management operational readiness

  • Ensure execution excellence in NPI & LCM projects ensuring that processes delivered are robust and ready for commercial operation
  • Ensure the manufacturing facility is operationally ready by establishing a structure to deliver procedures, batch records, business processes and training in line with project plans

Develop the organisation ensuring effective talent management and succession planning

  • Build a high-performing organization with clear objectives that delivers results aligned with Amgen Values and Leadership Attributes
  • Develop and maintain an effective organisation through selection, coaching, leadership and talent development
  • Ensure depth of succession across all levels within manufacturing
  • Foster a culture that is inclusive and welcomes diversity in thought and execution

OTHER RESPONSIBILITIES:

  • Member of the ADL Manufacturing Leadership team
  • Member of the Site Operating team
  • Member of the Site Extended Leadership team
  • Leader and contributor to site and network initiatives to improve operational performance
  • Participant and Leader of Global Network initiatives

BASIC QUALIFICATIONS:

  • BSc in science, engineering or equivalent with additional qualifications (Masters/PhD) advantageous
  • 10+ years experience in management of GMP manufacturing
  • Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs

PREFERRED QUALIFICATIONS:

  • Strong technical background with experience in facility start up, tech transfer and high volume manufacturing - in particular aseptic manufacturing knowledge and experience are key
  • Significant experience in biotechnology, leading development and execution of cross functional, complex technical projects
  • Thorough knowledge of all relevant cGMPs
  • Experience managing in a unionised environment
  • Awareness and understanding of quality and regulatory industry trends, policies and guidelines
  • Proven experience in the creation of organisations with a defect elimination mindset and metrics driven culture
  • Proven skills in building and maintaining productive relationships with organizational partners such as Process Development, Engineering and Quality
  • Excellent project management skills with the ability to lead effectively in a highly matrixed organization
  • Excellent communication skills able to work with and influence executive management
  • Strong understanding of validation of biopharmaceutical facilities, equipment and process
  • Breadth of experience across disciplines to understand all aspects of technology transfer in order to ask the right questions and challenge appropriately

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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