Senior Associate, Manufacturing

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.

Let’s do this. Let’s change the world. In this vital role you will report into the Shift Manager. In this role, you will have responsibility for activities relating to the manufacture of sterile parenteral drugs.  

The Amgen Manufacturing Site is a fast-paced and evolving environment, focused on continuous improvement of work processes and practices. Flexibility is key. You may be asked to carry out additional work functions, associated with the role, as designated by management, at times. 

The successful candidate will be required to work a shift pattern.  

Key Responsibilities:

• →Support the Manufacturing Manager in leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and regulatory standards.
• →Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule.
• →Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans.
• →Maintain an accurate, up-to-date manufacturing schedule reflecting current status of production and plan critical path activities.
• →Foster a good safety culture in our team and act as a safety role model.

• →Oversee completion and review of documentation (batch records, EBRs) using relevant software systems and Standard Operating Procedures (SOPs).

• →Proactively identify training needs and facilitate completion of training to meet the area resource and cross training models.

• →Assist, plan and implement continuous improvement initiatives using lean principles.
• →Proactively identify and resolve process issues (including escalation and follow up) to minimize production disruptions.
• →Support and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.

• →Lead on the 24/7 shift team in the absence of the Manufacturing Manager.

We are all different, yet we all use our unique contributions to serve patients. The Senior Associate, Manufacturing professional we seek is an individual with these qualifications.

• Educated to pass Leaving Certificate standard or equivalent
• A third level qualification in a relevant subject area would be an advantage.
• Applicants should have relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment. Aseptic experience preferred.
• Significant experience in a GMP/other regulated environment.
• Demonstrated knowledge of GMP principles.
• Demonstrated aseptic knowledge in GMP areas.
• Drug product manufacturing experience.
• Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels.
• Demonstrated ability to deliver to team, site and personal objectives.

• Demonstrated understanding and use of right first-time techniques and lean manufacturing concepts.

• Results-oriented.
• Excellent organizational, communicational and team development skills.
• Strong understanding of the quality system requirements and regulations for working in an aseptic drug product facility.
• Excellent communication skills.

• Team leadership experience (preferred).
• Excellent computer skills - knowledge of Electronic Batch Records, Quality Management Systems and Performance management Systems.

• Fluent English required.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.