Manufacturing Manager - Shift Role - 24 / 7

Amgen; Dún Laoghaire; On-site; EUR 90,000 - 110,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Manufacturing Front Line Manager to lead a manufacturing team of over 20 technicians and senior associates in aseptic filling operations (Syringes/Vials). You will drive production targets, ensure GMP compliance, safety, and quality, and develop a high-performing team aligned with Amgen values.

You will manage cross-functional collaboration with Quality, Maintenance, Engineering, Planning and HR, maintain production schedules, lead problem solving, and contribute

Qualifications

• Bachelor’s degree in Engineering or Science or related discipline required.
• 5+ years’ experience in Syringe/Vial aseptic manufacturing operations or GMP manufacturing experience preferred.
• Experience leading and developing manufacturing teams required.
• Familiarity with GMP, EH&S and regulatory standards is essential.
• Strong problem-solving, coaching and performance management capabilities requested.

Responsibilities

• Lead a shift of over 20 manufacturing technicians and senior associates on a four-cycle rotation.
• Ensure adherence to production schedules and GMP requirements.
• Coach and develop the team, driving MAP performance and training.
• Facilitate daily scheduling meetings and maintain up-to-date production plans.
• Collaborate with Maintenance, Engineering, Quality, Planning and HR to achieve plant objectives.
• Lead lean improvement initiatives and drive continuous improvement.
• Support audits by regulatory bodies and ensure quality documentation is complete.

Skills

Leadership

GMP knowledge

Lean manufacturing

Aseptic manufacturing

Team management

Electronic Batch Records

Education

Bachelor’s degree in Engineering or Science or related discipline

Tools

PAS/X

QMTS

MAPs

Job description

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) 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 FLM 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 FLM facilitates daily scheduling and work centre team meetings ensuring that all groups are aligned on all critical activities to meet the manufacturing plan.
• The FLM will ensure that the production finite schedule is maintained up to date to reflect the status of the manufacturing process.
• The FLM will lead problem solving on their shift working with the cross functional support groups in the identification of process related issues with effective resolution to minimize impact on the manufacturing schedule.
• Act as Aseptic Coach by continuously observing and advising on aseptic practices in the manufacturing clean rooms.
• The FLM is responsible for ensuring that her/his team are compiling, maintaining, and reviewing all necessary reports, documentation batch records/ EBRs relevant to the manufacturing area including use of relevant software systems and standard operating procedures.
• The FLM will effectively collaborate and liaise with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services and Human Resources organizations to achieve objectives of the Manufacturing Department.
• The FLM will be 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 FLM will proactively identify training needs for their manufacturing shift and direct reports and facilitate completion of training as per Amgen’s learning Management System and production requirements.
• The FLM will implement lean practices and assist, plan and implement continuous improvement ideas and opportunities using lean principles.
• The FLM will contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.
• The FLM will complete any other duties as requested by Manufacturing Management.

Basic Qualifications & Relevant Experience preferred:

• 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
• Previous experience in managing and leading teams

Preferred:

• Demonstrated understanding and use of RFT 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.