Manufacturing Manager (MES) – Amgen
Location: Amgen Dun Laoghaire, Dublin, Ireland
Overview
As the Manufacturing Manager – MES at Amgen Dun Laoghaire, you will report to the Senior Manager Manufacturing and lead a team of MES designers to generate Master Batch Records. You will ensure records are delivered in compliance with Good Manufacturing Practices and adhere to the Manufacturing Schedule, covering NPIs/LCMs, revisions of commercial records, and capital project updates.
Responsibilities
Recruit and onboard MES personnel to meet project targets and manufacturing schedule adherence.
Monitor resources and training models to ensure appropriate staffing meets project targets.
Assist in assessment and development of impact/resource models for New Product and Project siting assessments.
Develop the MES team through training and coaching.
Manage direct reports, ensuring performance standards are met and creating a high‑performing team.
Participate in goal‑setting for the team and manage complex goals aimed at creating competitive advantage.
Build and foster collaborative relationships within the team and cross‑functional teams.
Promote a culture of safety, ensuring team engagement and alignment with site safety initiatives.
Support ongoing development and improvement of the Amgen Dun Laoghaire MES system, MES process, and implementation of MBR improvement opportunities.
Support training of Electronic Batch Record (EBR) end‑users where required.
Develop, review, and update MES Standard Operating Procedures.
Ensure adherence to established timelines and metrics for the change control and deviation process, providing expertise and support to investigations.
Contribute and assist with audits by Corporate, FDA, HPRA, and other regulatory agencies.
Support equipment integration design, configuration, and testing to allow MBR interaction with shop floor equipment.
Liaise with Amgen MES core‑team to troubleshoot and develop new ways of working.Provide technical support where required and as directed by Operations leadership.
Perform any additional responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.
Qualifications
Experience in the pharmaceutical or biotech industry with demonstrated competency in leading teams to deliver complex MBR designs within project timelines.
Broad technical experience in MES systems and Master Batch Record delivery.
Commitment to continuous improvement, improving team efficiency.
Demonstrated experience working in cross‑functional work center teams and handling multiple projects simultaneously.
Bachelor’s degree in Engineering or Science.
Five or more years’ experience in syringe/vial aseptic manufacturing operations, or demonstrated capacity to learn quickly and adapt to new technology.
Previous experience with MES platforms and MBR delivery, ideally PAS│X.
Working knowledge of parenteral processes in pharmaceutical/biotech industries or aseptic processing.
Knowledge of regulatory requirements (GMP & EH&S).
Previous experience in managing and leading teams.
Excellent written and verbal communication skills, including facilitation and presentation skills.
Strong leadership, technical writing, negotiation, and influencing skills.
Ability to deal with complexity and ambiguity.
Ability to lead, motivate, coach, and mentor teams.
Excellent teamwork skills with ability to collaborate, communicate, and be accountable.
Data‑driven decision‑making skills.
Proficiency in managing relationships with stakeholders and coordinating/collaborating across departments to achieve common goals.
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