Manufacturing Manager (Manufacturing Support)

Amgen; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Manufacturing Manager - Manufacturing Support to oversee NPI, LCM changes and major CAPEX projects for Formulation and Aseptic Filling. You will lead a team of Operations Leads, coordinate with QA, QC and Regulatory, and ensure adherence to GMP.

The role requires strong leadership, project management and problem-solving skills to improve process efficiency and product quality.

Qualifications

• 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.

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

Education

Bachelor's degree in Engineering or Science

GMP / GxP knowledge

Leadership

Cross-functional teamwork

Project management

Aseptic drug product manufacturing

Communication skills

Problem solving

Negotiation & influencing

Mentoring & coaching

Job description

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.

Level 5 - Amgen Dun Laoghaire – Dublin

Overview:

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.