Syringe Manufacturing Front Line Manager

1 week ago

Dublin, Dublin City, Ireland Amgen SA Full time

ADL – Level 5 - Amgen Dun Laoghaire - Dublin

Overview:

The PM3 syringe manufacturing front line manager (FLM) will report to the Sr. Manager and will be responsible for ensuring continuity and standardisation of 24x7 operations while providing managerial oversight on a 16x5 shift pattern to the manufacturing team up to Sr Associate level. The ideal candidate will have at least five to ten years of experience within the pharmaceutical or biotech industry and will have demonstrated competency in a manufacturing people management role.

The ideal candidate will have:

  • Experience working in an aseptic or GMP environment in a supervisory or management position.
  • The ability to influence and lead cross-functional teams to deliver both tactical and strategic objectives to ensure patient supply today and into the future.
  • A commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates.
  • A passion for embracing a culture of diversity, inclusion, and belonging within our workforce to ensure Amgen remains a best place for talent.

Job Scope:

Production Management

  • Ensuring Safety, Quality and Compliance
    • Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported and investigated in a timely manner. Promotes a positive safety culture within PM3.
    • Works in a collaborative manner with other functions to ensure robust deviation investigations and assumes ownership of subsequent CAPAs to prevent reoccurrence.
    • Contributes to and assists with Corporate, FDA, HPRA, and other regulatory agencies during GMP audits and is responsible for corresponding follow-up actions.
    • Ensures the manufacturing area adheres to all relevant regulatory guidance documents.
    • Accountable for ensuring that all staff maintain necessary training qualifications and operate in compliance with SOPs and GMP standards.
      • Accountable for Delivering Results by:
        • Participating in the goal-setting process for the department and managing complex goals aimed at creating competitive advantage.
        • Supporting the shift teams by providing on-the-floor holiday/absence cover, problem-solving, and project support.
        • Supporting the creation of short, medium, and long-term schedules and being accountable for the on-time in full execution against the plan.
        • Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan.
        • Communicating issues and promptly escalating issues that may jeopardize manufacturing deliverables.
        • Using project management principles to lead complex cross-functional initiatives.
          • Supporting cross-functional engineering, process development, and maintenance teams to improve the reliability of existing equipment.
          • Recognizing positive performance and sharing best practices with other shifts, departments, and sites within the network.
          • Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognize positive contributions.
          • Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance-related deviations.
          • Leading and sponsoring lean initiatives such as Kaizen events, A3 projects, 5S initiatives, and CI ideas to create a culture of continuous improvement.
            • Accountable for Communication and Escalation
              • Strong communication skills both written and orally with the power to influence at different levels of the organization.
              • Providing manufacturing performance updates at various forums to audiences including senior leadership.
              • Escalating any issues which cannot be resolved locally in accordance with Amgen's escalation policy.

People Management:

  • Responsible for developing the best team by:
    • Recruiting, interviewing, and onboarding staff to meet headcount requirements in accordance with resource models.
    • Developing staff competencies through training, coaching, and succession planning to ensure a pipeline of talent to progress through the organization.
    • Creating a culture of diversity, inclusion, and belonging to ensure every team member feels valued at Amgen.
    • Managing direct reports using MAP performance management systems to ensure they meet the required performance standards, addressing issues with individuals where required to create a high-performing team.
      • Being responsible for effective management of all direct reports including people management in line with the company's disciplinary policy and standards, including active management of absenteeism, tardiness, lateness, and holidays.

Basic Qualifications & Relevant Experience Preferred:

  • Typically, 5 – 10 years' experience in a GMP environment with a level of people leadership experience.
  • Bachelor's degree in a relevant science or engineering-related discipline.
  • Working knowledge of aseptic manufacturing operations.
  • Knowledge of GMP regulation requirements mainly FDA and HPRA specifically related to the manufacture of parenteral drug products.
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