Amgen Senior Associate - Manufacturing (Shift) in Dublin, Ireland

Overview:

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 to coach/mentor a team on the quality system requirements. The candidate will have excellent troubleshooting skills using standard industry problem solving techniques and they will be required to work on a shift pattern.

Job Summary:

  • Support the Manufacturing Manager in managing a shift 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 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 a 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 Experience:

  • 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.