Manufacturing Manager
Manufacturing Manager
Ireland - Dun Laoghaire APLICAR AHORAManufacturingFront Line Manager
Amgen Dun Laoghaire
Live
What you will do
Let’sdo this.Let’schange the world. As part of Amgen’s Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.
The Manufacturing Front Line Manager (FLM) at Amgen Dun Laoghaire is a key member of the Operations Leadership Team, leading a team of 20+ Manufacturing Process Technicians and Senior Associates on a four-cycleshift rotation.They oversee formulation and aseptic filling of Amgen’s drug products (syringes/vials), in compliance with Good Manufacturing Practices.
The FLMoverseesshift operations to ensure adherence to the production schedule, collaborating with support functions (Maintenance, Engineering, Quality, Planning).Theymaintainastrong culture of Safety and Quality within their team and in the manufacturing area overall.
TheFLMdevelops and coaches a high-performing team of Manufacturing ProcessTechnicians/Associates,fostering a culture aligned with Amgen values and leadership attributes that supports team growth while delivering exceptional results in a leading biotechnology business.
Thesuccessful candidate willbe requiredto work a shift pattern.
Key Responsibilities:
ModelAmgen’s values and leadership attributes,ensuring all cleanroom activities meet the highest standards of quality and safetywhile adhering to the manufacturing schedule.
Manage a shift of Process Technicians to achieve production targets efficientlyin accordance withGMP, safety, and other regulatory standards.
Facilitate daily scheduling and team meetings to align all groups on critical activities to meet the manufacturing plan.
Support the commissioning, qualification, and product transfer of Amgen’s drug products to the new filling line.
Driveproblem-solving efforts on the shift, workingwith cross-functional teams to minimize schedule disruptions.
Act as Aseptic Coach byobservingand advising on aseptic practices in the manufacturing clean rooms.
Ensurethe team compiles,maintains, and reviews all necessary reports and documentation, including batch records/EBRs,usingappropriate systemsand SOPs.
Collaboratewith Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services, and Human Resources to achievedepartmentobjectives.
People management, includingteam development,engagementand ongoing performancereviewsvia the Maximizing Amgen’s Performance (MAP) process, ensuring clarity and accountability for expected performance levels.
Identifytraining needs andfacilitatecompletion per Amgen’s Learning Management System and production requirements.
Implement lean practices andsupportscontinuous improvement opportunities using lean principles.
Assistwithaudits fromcorporate, FDA, HPRA, and other regulatory bodies.
Win
What we expect of you
Thesuccessful candidate for this role will bring the following education,skillsand experience
Bachelor’s degree in engineering or science.
Knowledge of relevant regulations and regulatory requirements (GMP, EH&S).
5+ years’ experience in Syringe/Vial aseptic manufacturing operations ordemonstratedcapacity to learn quickly and adapt tonew technology.
Previousexperience in managing and leading teams.
Understanding and use of RFT techniques and lean manufacturing concepts.
Excellentpeople managementskills, including performance management, coaching, mentoring, and team development.
Ability to lead, challenge, and positively influence in a team environment.
Proficient computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS), and personnel performance tracking (MAPs).
Fluent Englishrequired.
Thrive
What you can expect of us
In addition to the base salary, Amgen offers a Total Rewards Plandesigned to support your health, financial wellbeing, work/life balance, and long-term career growth.Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents,retirement andsavingsplan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program.Exceptional learning, development, and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.
Amgen is an equal opportunity employer.