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Amgen Senior Associate Manufacturing (Shift) in Dun Laoghaire, Ireland

This position will report to the Manager Manufacturing. The ideal candidate will provide strong management and leadership to the Manufacturing teams in a sterile Drug Product facility. They will have strong GMP and quality system knowledge and the ability coach/mentor a team on the quality system requirements. The candidate will have excellent troubleshooting skills using standard industry problem solving techniques.

Job Summary:

  • Support the Manufacturing Manager in managing a shift (combination of days/& nights) of Process Technicians to achieve production targets efficiently in line with GMP, safety and other regulatory standards.

  • Ensure shift Process Technicians are given clear direction and information to perform daily tasks as per the production schedule.

  • Facilitate daily scheduling meetings. Ensure current the manufacturing schedule is accurate, and up to date reflecting current status of production.

  • Be responsible for compiling, maintaining and reviewing all necessary reports, documentation batch records/ EBRs relevant to the manufacturing area including use of relevant software systems and standard operating procedures.

  • Collaborate and liaise with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services and Human Resources organizations to achieve objectives of the Manufacturing Department.

  • Manage direct reports for time and attendance in line with the company’s disciplinary policy and standards, performance management & development including annual reviews via the Maximizing Amgen’s Performance (MAP) process, ensuring they have a clear understanding and are accountable for the performance levels expected of them.

  • Proactively identify training needs for their manufacturing shift and direct reports and facilitate completion of training as per MAP, LMS or production requirements.

  • Assist, plan and implement continuous improvement ideas / opportunities using lean principles.

  • Be proactive in the identification of process related issues including escalation & follow up for effective resolution to minimise impact on the manufacturing schedule.

  • Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits.

  • Complete any other duties as requested by Manufacturing Management.

  • Basic Requirements

  • Educated to degree level or equivalent in an scientific/engineering discipline

  • Must have relevant aseptic experience of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment

  • 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.

  • Strong understanding of the quality system requirements and regulations for working in an aseptic drug product facility and ability to communicate those requirement to the manufacturing team.

  • Demonstrated ability to deliver to team, site and personal objectives.

  • Preferred:

  • Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.

  • Strong people management experience including performance management, coaching, mentoring and development of the manufacturing team.

  • Strong ability to lead, challenge and positively influence in an interactive team environment

  • Strong computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS) and personnel performance tracking (MAP’s) etc.