Amgen Senior Associate Manufacturing (Shift Role) in Dublin, Ireland
This position will report to the Manager Manufacturing at Amgen Dun Laoghaire, Co. Dublin. The ideal candidate will provide strong management and leadership in the Manufacturing & Operations area with previous experience in aseptic processing in sterile Drug Product facility. Strong GMP and Quality System knowledge and ability coach/mentor the team on the Quality System requirements. Excellent troubleshooting skills using standard techniques for Root Cause Analysis. Please note this is a shift role.
Manage a shift of Process Technicians to achieve production targets efficiently in line with GMP, safety and other regulatory standards. Manage direct and indirect reports to ensure they are given clear direction, are suitably motivated and have a clear understanding as to the performance levels expected of them.
Be responsible for effective management of all direct reports including people management in line with the company’s policies and standards.
Responsible for effective performance management & development of direct reports, including annual reviews of direct reports 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 identifying operational improvement opportunities or process related issues including escalation & follow up with cross functional teams for effective resolution and implementation.
Proactively identify training needs for all direct reports and to facilitate completion of training as per MAP, LMS or production requirements.
Be responsible for compiling, maintaining and reviewing all necessary reports and documentation relevant to manufacturing area including use of relevant software systems and standard procedures.
Collaborate and network with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services and Human Resources organizations to achieve objectives of the Manufacturing Department.
Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
Complete any other duties as requested by Manufacturing Management. Basic Requirements
Must have relevant aseptic experience of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment
Ideally have demonstrated strong people management experience
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
Demonstrated ability to deliver to team, site and personal objectives
Educated to degree level or equivalent in an appropriate discipline
Demonstrated understanding and use of RFT techniques and lean manufacturing concepts
Strong ability to lead, challenge and positively influence in an interactive team environment
Strong computer skills - knowledge of CMMS, Electronic Batch Records, MAP’s etc.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.