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Job Description

Manufacturing Senior Associate – L4

Amgen Dun Laoghaire

Live

What you will do

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 Senior Associate reports to the Manager Manufacturing. The ideal candidate will provide strong leadership to the Manufacturing teams. They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements as well as maintaining a strong culture of safety within their shift team and in the manufacturing area in general. The candidate will have excellent troubleshooting skills using standard industry problem solving techniques. The successful candidate will build on a culture of diversity, inclusion and belonging in fast-paced and evolving environment. The candidate will have a continuous improvement mindset to drive changes in efficiency, safety, compliance, and quality.

The successful candidate will be required to work a shift pattern. This role will begin as a days position, moving to 24/5 shift pattern in the future.

Key Responsibilities:

• Responsible for leading the shift in conjunction with FLM. Responsible for outlining roles for the day, ensuring schedule is on track, triaging events, writing deviations, Batch Record Review. Running MDI’s.
• Oversees opportunities from project from training perspective in project phase.
• Support development of SOPs/job-aids/guidance.
• 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 shift team in the absence of the Manufacturing Manager.

Win

What we expect of you

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

• 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.
• Demonstrated ability to work within an AI Mindset
• 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.

Thrive

What you can expect of us

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.