Amgen Jobs

Overview:

This position will report to 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. 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 leading a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and other regulatory standards in an assigned process area.

• 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 on objectives and action plans.

• Ensure the manufacturing schedule is accurate and up to date reflecting current status of production and clearly plan out all critical path activities for assigned process area.

• Foster a good safety culture in our team and act as a safety role model

• 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.

• Proactively identify training needs for their manufacturing shift and facilitate completion of training to meet the area resource and cross training models.

• 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.

• Takes the lead on the 24/7 shift team in the absence of the Manufacturing Manager

Basic Requirements:

• Educated to degree level or equivalent in a scientific or engineering discipline

• Must have relevant aseptic experience within 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 right first time techniques and lean manufacturing concepts.

• Team leadership experience leading a process area in the manufacture of sterile drug

• 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) etc.