PM2 Manufacturing Manager (Days)

Let’s do this. Let’s change the world. As part of Amgen’s Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.

The Manufacturing Front Line Manager (FLM) at Amgen Dun Laoghaire is a key member of the Operations Leadership Team, leading a team of 20+ Manufacturing Process Technicians and Senior Associates on a four-cycle shift rotation. They oversee formulation and aseptic filling of Amgen’s drug products (syringes/vials), 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. 

• →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.

The successful candidate for this role will bring the following education, skills and experience

• 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.

• 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).
• Fluent English required.

In addition to the base salary, Amgen offers a Total Rewards Plan designed to support your health, financial wellbeing, work/life balance, and long-term career growth. 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, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.

Amgen is an equal opportunity employer.