Manufacturing Manager (Manufacturing Support)

1061 Amgen Technology (Ireland) UC; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen Dun Laoghaire in Dublin seeks a Manufacturing Manager for Manufacturing Support. You’ll oversee NPI, LCM changes and major CAPEX for Formulation and Aseptic Filling, ensuring GMP compliance and safe product quality. Lead a team of Operations Leads, mentor staff, and drive process improvements while coordinating with cross-functional partners.

Strong leadership and project management are essential. This role provides site visibility, involvement in regulatory readiness, and opportunities

Qualifications

• Bachelor’s degree in Engineering or Science.
• Strong GMP and other applicable GxP knowledge.
• Experience in cross functional teams handling multiple projects.
• 5+ years’ experience in Syringe/Vial aseptic Drug Product manufacturing operations or demonstrated leadership.
• Excellent written and verbal communication skills.
• Strong leadership, negotiation and influencing skills.
• Ability to deal with complexity and ambiguity.
• Lead, motivate, coach, and mentor teams.
• Project management across multiple projects and resources.

Responsibilities

• Monitoring resources and training models to meet project targets.
• Builds collaborative relationships within the team and with other departments.
• Coach and develop team of Operations Leads.
• Promote a culture of safety and site safety initiatives.
• Deliver project plans in accordance with manufacturing and project requirements.
• Communicate information to peers, operators, cross functional departments, and senior management.
• Act as a delegate for the Snr Manager Manufacturing as required.
• Evaluate, plan, and implement process improvement opportunities.
• Provide expertise for quality system investigations and regulatory audits.

Skills

Leadership

Project management

Communication

GMP/GxP knowledge

Aseptic manufacturing

Education

Bachelor’s degree in Engineering or Science

Job description

Career Category Manufacturing Job Description Manufacturing Manager (Manufacturing Support) Level 5 - Amgen Dun Laoghaire – Dublin Overview: The Manufacturing Manager - Manufacturing Support at Amgen Dun Laoghaire reports to the Senior Manager Manufacturing and provides oversight of New Product Introduction (NPI), Life Cycle Management changes (LCM) and/or major capital Expenditure (CAPEX) Projects for the Formulation and Aseptic Filling areas in compliance with Good Manufacturing Practices. The Manufacturing Manager manages the daily work of direct reports responsible for Manufacturing Projects. Champions driving process efficiencies as part of the projects that are being introduced to operations. Mentors’ employees by sharing technical expertise and guidance. Establishes priorities and deliverables for team in line with organisational goals and business objectives. Plans and organises all project assignments /resourcing on projects of various complexity. Translates complex data into actionable information. Supports coordination of activities across business units and exercises decision making independently. Has broad manufacturing, tech transfer & compliance knowledge. Identifies process gaps and introduces innovative solutions to improve operating efficiencies. Can clearly articulate, educate and challenge others. Interfaces with management on significant matters.

Responsibilities:

• Monitoring resources and training models to ensure that appropriate resource/staff management to meet project targets
• Builds and fosters collaborative relationships within his/her team and other departments
• Coach and develop team of Operations Leads
• Promotes a culture of safety, ensuring the team is engaged and aligned with the site safety initiatives
• Deliver project plans in accordance with agreed manufacturing & project requirements
• Effectively communicate relevant information to peers, manufacturing operators, cross functional departments, and senior management
• Act as a delegate for the Snr Manager Manufacturing as required
• Evaluate, plan, and implement solutions for process improvement opportunities
• Provide expertise and support for quality system investigations ensuring timely and effective assessment of events and appropriate actions to protect product quality and patient safety
• Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits

Qualifications & Relevant Experience preferred:

• Bachelor’s degree in Engineering or Science.
• Strong GMP and other applicable GxP knowledge.
• Demonstrated experience working in cross functional work centre teams with the ability to handle multiple projects simultaneously.
• 5+ years’ experience in Syringe/Vial aseptic Drug Product manufacturing operations or have a demonstrated leadership skills with the capacity to learn quickly and adapt to new technology.
• Excellent written and verbal communication skills including facilitation and presentation skills.
• Demonstration of strong leadership, negotiation and influencing skills.
• Ability to deal with complexity and ambiguity.
• Demonstrated ability to lead, motivate, coach and mentor.
• Excellent teamwork skills with the ability to collaborate, communicate and be accountable.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

Salary Range EUR - EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen