Manufacturing Manager

Amgen; Dublin; On-site; EUR 79,000 - 106,000; Full time

Job summary

Amgen Dun Laoghaire seeks a Manufacturing Day Manager to join the PM3 Manufacturing Extended Leadership Team, ensuring safe, compliant and effective operation. You will drive production plan delivery, support audits, and foster continuous improvement across the manufacturing network.

Responsibilities include developing staff, coordinating schedules, and maintaining training standards with a strong focus on safety, quality and timely delivery of products to patients.

Qualifications

• Typically 5–10 years of GMP experience in a manufacturing environment.
• Bachelor's degree in a relevant science or engineering discipline.
• Working knowledge of aseptic manufacturing operations.
• Knowledge of GMP regulatory requirements (FDA/HPRA) for parenteral drug products.

Responsibilities

• Ensure safe operation, quality, and compliance in the manufacturing area.
• Lead cross-functional collaboration to support deviations, CAPAs and audits.
• Manage shift teams, staffing, training and performance development.
• Drive continuous improvement using Lean, Gemba walks and CI initiatives.

Skills

GMP experience

People leadership

Aseptic manufacturing

Regulatory knowledge

Education

Bachelor's degree in relevant science or engineering

Job description

Career Category Manufacturing Job Description

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses - drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let's do this. Let's change the world.

The Manufacturing Day Manager at Amgen Dun Laoghaire is a key member of the PM3 Manufacturing Extended Leadership Team ensuring the PM3 plant operates safely, compliantly and effectively. The Day Manager plays a key role in supporting the wider manufacturing team to help deliver on the production plan whilst driving a culture of continuous improvement. The role maintains GMP and training standards, leads deviation investigations and CAPAs, supports regulatory audits, supports shift teams, and resolves or escalates issues that could affect delivery. It also recruits, develops and manages team members, building an inclusive, accountable and high-performing team.

Production Management

Ensuring Safety, Quality and Compliance

Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported and investigated in a timely manner. Promotes a positive safety culture within manufacturing. Works in a collaborative manner with other functions to ensure robust deviation investigations and assumes ownership of subsequent CAPAs to prevent reoccurrence. Contribute to and assist with Corporate, FDA, HPRA and other regulatory agencies during GMP audits and is responsible for corresponding follow up actions. Ensure the manufacturing area adheres to all relevant regulatory guidance documents. Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP’s and to GMP standards. Accountable for Delivering Results by: Participate in the goal setting process for the department and manage complex goals aimed at creating competitive advantage. Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support. Supporting the creation of short, medium- and long-term schedules and being accountable for the on time in full execution against the plan. Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan. Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables. Using project management principles to lead complex cross functional initiatives. Supporting cross functional engineering, Process development and maintenance teams to ensure right first time execution during project and commercial operation. Recognising positive performance and sharing best practices with other shifts, departments and sites within the network. Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognise positive contributions. Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance related deviations. Leading and sponsoring lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement. Accountable for Communication and Escalation Strong communication skills both written and orally with the power to influence at different levels of the organisation. Providing manufacturing performance updates at various forums to audiences including senior leadership. Escalating any issues which cannot be resolved locally in accordance with Amgen’s escalation policy.

People management

Responsible for developing the best team by: Recruiting, interviewing, and onboarding staff to meet headcount requirements in accordance with resource models. Developing staff competencies through training, coaching and succession planning to ensure a pipeline of talent to progress through the organisation. Creating a culture of diversity, inclusion and belonging to ensure every team member feels valued at Amgen. Managing direct reports using MAP performance management systems, to ensure they meet the required performance standards, addressing issues with individuals where required to create a high performing team. Be responsible for effective management of all direct reports including people management in line with the company’s disciplinary policy and standards, including active management of absenteeism, tardiness, lateness, and holidays.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The successful candidate will hold the following: Typically, 5 - 10 years experience in a GMP environment with a level of people leadership experience. Bachelor's degree in relevant science or engineering related discipline. Working knowledge of aseptic manufacturing operations Knowledge of GMP regulation requirements mainly FDA and HPRA specifically related to the manufacture of parenteral drug product.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range

78,613.10 EUR - 106,358.90 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.