Senior Associate Manufacturing

ManufacturingSeniorAssociate – L4

Amgen Dun Laoghaire

Live

What you will do

Let’sdo this.Let’schange 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 reportsto the Manager Manufacturing. The ideal candidate will provide strong leadership to the Manufacturing teams on a 24/7 shift pattern in a sterile Drug Product facility in fast paced and evolving environment. They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements as well asmaintaininga 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.

Thesuccessful candidates willbe requiredto work a shift pattern. 

KeyResponsibilities:

• 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 onobjectivesand action plans.

• Maintainan accurate, up-to-date manufacturing schedule reflectingcurrent statusof 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).

• Proactivelyidentifytraining needsandfacilitatecompletion of training to meet the area resource and cross training models.

• Assist,planand implement continuous improvement initiatives using lean principles.

• Proactivelyidentifyand resolve process issues (including escalation and follow up) to minimize production disruptions.

• Supportandassistwith corporate, FDA, HPRA and other regulatory bodies during company audits.

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

Win

What we expect of you

Thesuccessful candidate for this role will bring the following education,skillsand 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 experiencein a GMP/other regulated environment.

• Demonstrated knowledge of GMP principles.

• Demonstrated aseptic knowledge in GMP areas.

• Drug product manufacturing experience.

• Experience working with equipmentutilizedin the manufacture of parenteral products such as autoclaves, fillinglinesand formulation vessels.

• Demonstrated ability to deliver to team,siteand personalobjectives.

• 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).

• Excellentcomputer skills - knowledge of Electronic Batch Records, Quality Management Systems and Performance management Systems.

• Fluent Englishrequired.

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 andsavingsplan with generous company contributions, group medical,lifeand disability insurance.Discretionary annual bonus program.Exceptional learning, development, and career advancement opportunities,empowering employees to growand 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.