Manufacturing Manager (Manufacturing Support)

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

Job summary

Amgen Dun Laoghaire, Dublin, seeks a Manufacturing Manager (Manufacturing Support) to oversee NPI, lifecycle changes and CAPEX projects for Formulation and Aseptic Filling. The role leads a team, mentors staff, and ensures safety and compliance with GMP/GxP while driving process improvements and coordinating with QA, regulatory and operations.

The candidate will manage project plans, resource allocation, and cross-functional collaboration, while upholding patient safety and product quality

Qualifications

• Bachelor’s degree in Engineering or Science.
• Strong GMP and GxP knowledge.
• Experience leading cross-functional teams on multiple projects.
• Excellent communication, facilitation and presentation skills.
• 5+ years in Syringe/Vial aseptic Drug Product manufacturing or equivalent leadership.

Responsibilities

• Monitor resources and training models to meet project targets.
• Build collaborative relationships within teams.
• Coach and develop Operations Leads.
• Promote a culture of safety on site.
• Deliver project plans in line with manufacturing and project requirements.
• Communicate relevant information to peers, operators, cross functional departments, and senior management.
• Act as a delegate for the Senior Manager Manufacturing as required.
• Evaluate, plan, and implement process improvements.
• Support quality system investigations ensuring timely and effective actions to protect product quality and patient safety.
• Contribute to audits by regulatory bodies.

Skills

GMP/GxP knowledge

Leadership

Communication

Project management

Cross-functional collaboration

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