Snr Associate Manufacturing

Biopharma Careers; Dublin; On-site; EUR 56,000 - 76,000; Full time

Job summary

Amgen is seeking a PM3 Syringe Manufacturing Senior Associate (16x5 shift) to ensure 24/7 operational continuity in a GMP environment. This role reports to the Front Line Manager or Senior Manager and requires 2–5 years in pharma/biotech, with a bachelor’s degree in a science or engineering field.

You will lead cross functional teams, support Kaizen and CI initiatives, and ensure staff training and compliance with SOPs.

Qualifications

• Working knowledge of aseptic or GMP manufacturing operations.
• Ability to influence and lead cross functional teams to deliver objectives.
• Commitment to continuous improvement using lean principles.
• Typically, 2–5 years’ experience in GMP environment.
• Bachelor’s degree in relevant science or engineering discipline.

Responsibilities

• Takes a proactive approach to safety, quality and compliance and seeks opportunities to prevent adverse events.
• Contribute to and assist with regulatory audits during GMP inspections by agencies such as FDA and HPRA.
• Ensure staff maintains training qualifications and operates in compliance with SOPs and GMP standards.
• Review batch documentation to support timely release and shipping forecasts.

Skills

GMP experience

Leadership

Cross-functional teamwork

Communication skills

Lean principles

Education

Bachelor’s degree in science or engineering

Tools

Electronic Batch Records

PAS-X

LIMS

Job description

Career Category

Manufacturing

Job Description

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 PM3 Syringe Manufacturing Senior Associate (16x5 shift) reports to the Front Line Manager or Senior Manager and is responsible for ensuring 24/7 operational continuity and standardization. The role requires 2–5 years of experience in the pharmaceutical or biotechnology industry.

Key Responsibilities

Ensuring Safety, Quality and Compliance

• Takes a proactive approach to safety, quality and compliance and actively seeks opportunities to prevent adverse events from occurring.
• Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits.
• Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP’s and to GMP standards.
• Review manufacturing batch documentation both paper and electronic in a RFT manner to support timely release to support shipping and disposition cycle time (DCT) commitments.
• Support deviation management and investigations at various levels.

Accountable for Delivering Results by:

• Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support.
• Supporting the creation of short and medium- 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 improve the reliability of existing equipment.
• Recognising positive performance and sharing best practices with other shifts, departments, and sites within the network.
• Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans.
• 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 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

• Effective communication skills both written and orally with the power to influence at various levels of the organisation.
• Providing manufacturing performance and project updates at various forums to audiences including senior leadership.
• Escalating any issues which cannot be resolved locally in accordance with Amgen’s escalation policy.

What we expect of you

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

• Working knowledge of aseptic or GMP manufacturing operations
• Have the ability to influence and lead cross functional teams to deliver both tactical and strategic objectives to ensure patient supply today and into the future.
• Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates.
• Typically, 2 – 5 years’ experience in a GMP environment
• Bachelor’s degree in relevant science or engineering related discipline.
• Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.
• Demonstrated ability to deliver to team, site and personal objectives.
• Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.
• Strong ability to lead, challenge and positively influence in an interactive team environment.
• Strong computer skills - knowledge of Electronic Batch Records, PAS-X, Lims, etc.

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.

Salary Range

56,428.95EUR-76,345.05EUR