Career Category

Job Description

Sr. Associate Manufacturing

Level 4

Amgen Dun Laoghaire - Dublin

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 coach/mentor a team on the quality system requirements as well as maintaining a 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.

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.
• Foster a good Safety culture and act as a safety role model 
• Leads the shift team in the absence of the Manufacturing Manager
• 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 support functions; Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services and Human Resources, to help achieve objectives of the Manufacturing Department.
• Manage direct reports for time and attendance in line with the company’s policies 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 or engineering discipline

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

• Be results-oriented 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 requirements 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.