Manufacturing Manager (24/7 Shift Front Line Manager)
The Manufacturing Front Line Manager at Amgen Dun Laoghaire is a key part of the Operations Leadership Team leading a team of 20+ Process Technicians and Senior Associates on a 4-cycle shift rotation involved in Formulation and Aseptic Filling of biopharmaceuticals (Syringes/Vials) in compliance with Good Manufacturing Practices.
The Manufacturing Manager ensures adherence to the production schedule by actively managing operations during the shift in collaboration with support functions (Maintenance, Engineering, Quality, Planning).
They maintain a strong culture of Safety and Quality within their team and in the manufacturing area in general.
Job Summary: The Manufacturing Front Line Manager is a role model for Amgen's values and leadership attributes ensuring that all activities completed within the manufacturing clean rooms are executed to the highest standards of quality, protecting the safety of the manufacturing team while delivering on our manufacturing schedule commitments.
The Manufacturing Front Line Manager is responsible for effective management of a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and other regulatory standards.
The Manufacturing Front Line Manager facilitates daily scheduling and work centre team meetings ensuring that all groups are aligned on all critical activities to meet the manufacturing plan.
The Manufacturing Front Line Manager ensures that the production finite schedule is maintained up to date to reflect the status of the manufacturing process.
The Manufacturing Front Line Manager leads problem solving on their shift working with cross-functional support groups in the identification of process-related issues with effective resolution to minimize impact on the manufacturing schedule.
They act as an Aseptic Coach by continuously observing and advising on aseptic practices in the manufacturing clean rooms.
The Manufacturing Front Line Manager is responsible for ensuring that their team compiles, maintains, and reviews all necessary reports, documentation batch records/Electronic Batch Records (EBRs) relevant to the manufacturing area including use of relevant software systems and standard operating procedures.
The Manufacturing Front Line Manager effectively collaborates and liaises with Quality groups (Quality Control, Compliance, Inspection, and Assurance), Materials Management, Maintenance, Technical Services, and Human Resources organizations to achieve objectives of the Manufacturing Department.
The Manufacturing Front Line Manager is responsible for all elements of people management within their reporting line in line with the company's policy and standards, ensuring active engagement in the development of their team and ongoing performance assessments and management via the Maximizing Amgen's Performance (MAP) process, ensuring their team have a clear understanding and are accountable for the performance levels expected of them.
The Manufacturing Front Line Manager proactively identifies training needs for their manufacturing shift and direct reports and facilitates completion of training as per Amgen's Learning Management System and production requirements.
The Manufacturing Front Line Manager implements lean practices and assists, plans, and implements continuous improvement ideas and opportunities using lean principles.
The Manufacturing Front Line Manager contributes and assists with corporate, FDA, HPRA, and other regulatory bodies during company audits.
Basic Qualifications & Relevant Experience:
* Bachelor's degree in Engineering or Science or related discipline
* Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
* 5+ years' experience in Syringe/Vial aseptic manufacturing operations or have relevant GMP manufacturing experience and a demonstrated capacity to learn quickly and adapt to new technology
Preferred Qualifications:
* Demonstrated understanding and use of Root Cause Failure Technique (RCFT) techniques and lean manufacturing concepts.
* Strong people management experience including performance management, coaching, mentoring, and development of the manufacturing team.
* Strong ability to lead, challenge, and positively influence in an interactive team environment.
* Strong computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS), and personnel performance tracking (MAP's) etc.