Snr Manager Manufacturing

ADL: L6 - SENIOR MANAGER MANUFACTURING

Start-up Operational Readiness and Commercial Manufacturing Leadership

Reporting to the Director of Manufacturing the Senior Manager Manufacturing will lead the start-up operational readiness and transition to commercial operation of manufacturing activities at Amgen Dun Laoghaire.

The role has responsibility for Aseptic Filling Formulation Parts Preparation and Material Supply supporting drug product manufacture in syringe formats. A central priority is to build a capable compliant and high-performing organisation from the outset embedding a culture founded on safety quality accountability continuous improvement and a digital mindset.

As a member of the Manufacturing Leadership Team the successful candidate will provide visible leadership through site start-up qualification PPQ and commercial launch ensuring the organisation systems people and performance are ready to reliably deliver products for patients.

• Lead the Manufacturing Operational Readiness programme for Aseptic Filling Formulation Parts Preparation and Material Supply ensuring people procedures training systems materials equipment interfaces and governance are in place to support successful PPQ and commercial launch.
• Provide visible operational leadership for aseptic manufacturing activities ensuring sterile manufacturing practices contamination-control expectations; GMP compliance and inspection readiness are embedded in day-to-day operations.
• Working with the Manufacturing Director Ensure the Aseptic Filling organisation is fully prepared to execute PPQ successfully with appropriately trained personnel robust shift coverage clear standard work and effective escalation of process or quality risks.
• Recruit coach and develop Manufacturing Managers and frontline leadership creating a strong leadership pipeline and clear accountability throughout the organisation.
• Establish and sustain a strong safety quality compliance and patient-focused culture from day one; set clear behavioral expectations and ensure these remain central as the organisation grows.
• In collaboration with Mfg Director build the Manufacturing organisation from the ground up including workforce planning recruitment onboarding capability development and succession planning.
• Support successful PPQ execution ensuring operational teams are fully prepared risks are understood and mitigated and manufacturing performance meets schedule quality and compliance expectations.
• In collaboration with Mfg Director develop the operating model team routines tiered accountability performance-management processes and escalation pathways required for reliable day-to-day operations.
• Partner closely with Quality Engineering Supply Chain EHS Process Development Validation Automation and other cross-functional teams to deliver site start-up milestones and resolve barriers.
• Ensure plant resources and personnel are effectively planned and coordinated to safely meet product quality production schedule and cost objectives.
• Drive operational excellence through effective business systems visual performance management problem-solving capability and continuous improvement practices.
• Champion a digital mindset across the Manufacturing organisation using data digital tools and appropriate AI-enabled solutions to strengthen operational readiness simplify work improve decision-making and enhance team capability while maintaining GMP data-integrity and quality expectations.
• Lead the response to manufacturing issues using structured root-cause analysis robust corrective and preventative actions and effective learning across the organisation.
• Provide Manufacturing operational expertise and user requirements to process development technology transfer equipment qualification and new product introduction activities.
• Build collaborative relationships across the site and contribute actively to the development of the wider ADL culture and leadership team.

• 8 years of experience in pharmaceutical or similarly regulated manufacturing environments.
• 4 years of people management and leadership experience.
• Demonstrated experience leading teams through significant change scale-up start-up commissioning qualification PPQ or commercial launch activities.
• Bachelors degree or an equivalent combination of education and relevant experience.

• Direct experience in aseptic drug-product manufacturing including knowledge of GMP requirements and applicable regulatory expectations.
• Experience building expanding or transforming a manufacturing organisation including hiring onboarding training and development of leadership teams.
• Proven record of leading operational readiness and/or PPQ execution within a regulated manufacturing environment.
• Strong understanding of how to establish effective manufacturing operating systems including tiered meetings KPI management escalation and continuous improvement.
• Demonstrated digital fluency with the ability to use data digital technologies and appropriate AI-enabled tools to improve manufacturing performance capability and business processes within a GMP-regulated environment.
• Demonstrated ability to create a positive inclusive and accountable culture while maintaining high standards of safety quality and delivery.
• Strong analytical problem-solving skills and experience leading cross-functional teams through complex technical or operational challenges.
• Excellent communication skills with the ability to engage and influence frontline teams through senior leadership.

Salary Range