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Job Description

Manufacturing Manager (Manufacturing Support)

Level 5 - Amgen Dun Laoghaire - Dublin

Overview:

The Manufacturing Manager-Manufacturing Support at Amgen Dun Laoghaire forms part of the Operations Leadership team reporting to the Snr Manager Manufacturing and provides support to the Management team involved in Formulation and Aseptic Filling of biopharmaceuticals (Syringes/Vials) in compliance with Good Manufacturing Practices. The Manufacturing Manager establishes and maintains the manufacturing departs KPIs (Key Performance Indicators) and leads programs to ensure adherence to departments goals, objectives and action plans aimed to ensure adherence to the production schedule, highest standards in Environmental, Health and Safety, Quality and Compliance, Operational Excellence and building a culture of diversity, inclusion and belonging in the Manufacturing department at Amgen Dun Laoghaire – Dublin.

Job Summary:

Daily operations support:

• Establish and maintain the measurement systems that track the schedule adherence and output from the aseptic manufacturing areas
• Reporting on performance on all key performance indicators relating to Safety, Quality, and schedule Adherence and output
• Establish and implement programs to deliver the Manufacturing departments goals, objectives and action plans

Leadership & Team Building:

• Develop cross functional WCT (Work Centre teams) for each main process area within the manufacturing department and support team members through coaching, active feedback and providing opportunities for developing knowledge and skills
• Builds and fosters collaborative relationships within his/her team and other departments
• Effectively communicate relevant information to peers, manufacturing operators, cross functional departments, and senior management
• Monitoring resources and cross training models to ensure that appropriate resource/staff management to meet production targets
• Act as a delegate for the Snr Manager Manufacturing as required

Safety and Quality:

• Foster an excellent Safety culture and act as a safety role model for safe behaviors and actions
• Provide support to our team of safety champions and support investigation into safety incidents or near miss
• Act as aseptic coach for the operations team through observation and advising on aseptic practices in the manufacturing area
• Provide expertise and support for quality system investigations ensuring timely and effective assessment of events and appropriate actions to protect product quality and patient safety
• Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits

Continuous Improvement:

• Monitor trends in the MDI (Managing Daily Improvements) process and develop actions to address issues impacting delivery of the plan
• Lead effective problem solving for issues that affect the achievement of department objectives and establish and implement of counter measures
• Development of Leader Standard Work (LSW) for the Manufacturing Department aligned with the department’s goals, objectives, and action plans
• Be a role model for lean initiatives to continuously improve the manufacturing department and achievement of its objectives and value position

Basic Qualifications & Relevant Experience preferred:

• Bachelor’s degree in Engineering or Science
• Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
• 5+ years’ Management experience in Syringe/Vial aseptic manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology
• Experience in leading cross functional work center teams is an advantage
• Experience of implementation of lean initiatives in a highly regulated environment -Green Belt Qualification desirable