Manufacturing Manager Job at Amgen (Dun Laoghaire)

Job Description

The Manufacturing Front Line Manager (FLM) at Amgen Dun Laoghaire is a key member of the Operations Leadership Team. They oversee formulation and aseptic filling of Amgen’s drug products (syringes), in compliance with Good Manufacturing Practices. The FLM oversees shift operations to ensure adherence to the production schedule, collaborating with support functions (Maintenance, Engineering, Quality, Planning). They maintain a strong culture of Safety and Quality within their team and in the manufacturing area overall. The FLM develops and coaches a high-performing team of Manufacturing Process Technicians/Associates, fostering a culture aligned with Amgen values and leadership attributes that supports team growth while delivering exceptional results in a leading biotechnology business. The successful candidate will be required to work a shift pattern. This role will begin as a days position, moving to 24/5 shift pattern in the future.

Job Responsibility

Model Amgen’s values and leadership attributes, ensuring all cleanroom activities meet the highest standards of quality and safety while adhering to the manufacturing schedule
Manage a shift of Process Technicians to achieve production targets efficiently in accordance with GMP, safety, and other regulatory standards
Facilitate daily scheduling and team meetings to align all groups on critical activities to meet the manufacturing plan
Support the commissioning, qualification, and product transfer of Amgen’s drug products to the new filling line
Drive problem-solving efforts on the shift, working with cross-functional teams to minimize schedule disruptions
Act as Aseptic Coach by observing and advising on aseptic practices in the manufacturing clean rooms
Ensure the team compiles, maintains, and reviews all necessary reports and documentation, including batch records/EBRs, using appropriate systems and SOPs
Collaborate with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services, and Human Resources to achieve department objectives
People management, including team development, engagement and ongoing performance reviews via the Maximizing Amgen’s Performance (MAP) process, ensuring clarity and accountability for expected performance levels
Identify training needs and facilitate completion per Amgen’s Learning Management System and production requirements
Implement lean practices and supports continuous improvement opportunities using lean principles
Assist with audits from corporate, FDA, HPRA, and other regulatory bodies
Capable to work in high-pressure and fast paced environment that are inherent to large-scale project

Requirements

Bachelor’s degree in engineering or science
Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
5+ years’ experience in Syringe aseptic manufacturing operations or demonstrated capacity to learn quickly and adapt to new technology
Previous experience in managing and leading teams
Understanding and use of RFT techniques and lean manufacturing concepts
Excellent people management skills, including performance management, coaching, mentoring, and team development
Ability to lead, challenge, and positively influence in a team environment
Proficient computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS), and personnel performance tracking (MAPs)
Demonstrated ability to work within an AI Mindset
Fluent English required

What we offer

Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents
Retirement and savings plan with generous company contributions
Group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development, and career advancement opportunities

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Manufacturing Manager

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