Front Line Manager (24/7 Shift) Aseptic Fill/Finish

The Manufacturing Front Line Manager (FLM) at Amgen Dun Laoghaire is an integral part of the Operations Leadership Team, leading a Manufacturing Team of over 20 Manufacturing Process Technicians and Senior Associates on a four-cycle shift rotation involved in Formulation and aseptic filling of Amgen's drug products (Syringes/Vials) in compliance with Good Manufacturing Practices.

The Manufacturing Front Line Manager (FLM) is responsible for overseeing shift operations to ensure adherence to the production schedule, collaborating with support functions (Maintenance, Engineering, Quality, Planning). The FLM maintains a strong culture of Safety and Quality within their team and in the manufacturing area overall.

The Manufacturing Front Line Manager (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.

Job Summary:

• The Manufacturing Front Line Manager (FLM) exemplifies Amgen’s values and leadership attributes, ensuring all activities completed within the manufacturing clean rooms meet the highest standards of quality and safety while adhering to the manufacturing schedule commitments.
• The FLM manages a shift of Process Technicians to achieve production targets efficiently in accordance with GMP, safety, and other regulatory standards.
• The FLM facilitates daily scheduling and work centre team meetings to align all groups on critical activities to meet the manufacturing plan.
• The FLM supports the commissioning and qualification of the new isolator vial filling line and the transfer of Amgen's drug products onto the new filling line.
• The FLM leads problem-solving efforts on their shift, working with cross-functional support groups to identify and resolve process-related issues effectively to minimize manufacturing schedule impacts.
• The FLM acts as an Aseptic Coach by observing and advising on aseptic practices in the manufacturing clean rooms.
• The FLM ensures their team compiles, maintains, and reviews all necessary reports and documentation, including batch records/EBRs relevant to the manufacturing area, utilizing relevant software systems and standard operating procedures.
• The FLM collaborates with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services, and Human Resources to achieve the Manufacturing Department’s objectives.
• The FLM manages all elements of people management within their reporting line, ensuring active engagement in team development and ongoing performance assessments and management via the Maximizing Amgen’s Performance (MAP) process, ensuring clarity and accountability for expected performance levels.
• The FLM identifies training needs for their manufacturing shift and direct reports and facilitates completion of training per Amgen’s Learning Management System and production requirements.
• The FLM implements lean practices and assists in planning and implementing continuous improvement opportunities using lean principles.
• The FLM contributes to and assists with corporate, FDA, HPRA, and other regulatory body audits.

Basic Qualifications & Relevant Experience preferred:

• Bachelor’s degree in Engineering or Science
• Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
• 5+ years’ experience in Syringe/Vial aseptic manufacturing operations or demonstrated capacity to learn quickly and adapt to new technology
• Previous experience in managing and leading teams

• Preferred:

• Understanding and use of RFT techniques and lean manufacturing concepts
• Strong people management experience, 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)