About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
The Project Lead oversees the planning, execution, and delivery of key projects within the biopharmaceutical manufacturing facility, ensuring compliance with GMP. This role is responsible for leading cross-functional teams, managing timelines, budgets, and resources, and ensuring alignment with company goals. The Project Lead also manages a team of direct reports and outsourced service providers, fostering their professional growth and ensuring effective project execution.
The position will be responsible for managing, coaching and developing all aspects of these functions with input and local accountability for strategy, forward planning, safety, quality, delivery, cost and service performance.
Responsibilities:
- Project & Program Management: Lead end-to-end delivery of capital, process improvement, and new product introduction projects, including technology transfers. Oversee project planning, execution, resource coordination, risk management, and financial tracking while ensuring adherence to regulatory requirements.
- Leadership & Team Development: Provide strategic leadership to the Projects Team, fostering a high-performance culture through coaching, ownership, and accountability. Develop future leaders and SMEs, identify training needs, and build cross-functional collaboration across departments.
- Technical & Operational Execution: Drive process optimization, efficiency improvements, and cost reduction initiatives. Lead equipment commissioning, validation, and readiness in collaboration with engineering, quality, and production teams. Manage external vendors and contractors effectively.
- Strategic & Organisational Alignment: Contribute to site-level and global strategic planning, delivering key projects on time and within budget. Build a resilient infrastructure that supports innovation, quality, and long-term workforce and technology development.
- Performance, Compliance & Governance: Ensure all projects and operations meet GMP, GDP, environmental and safety regulations. Maintain audit readiness, develop KPIs and action plans, and foster continuous improvement in performance, compliance, and operational excellence.
- Change Management & Business Continuity: Lead successful implementation of technological and procedural changes. Mitigate risks, support crisis and business continuity planning, and future-proof teams, assets, and systems to sustain growth and strategic capability.
Education:
- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas, or equivalent.
Preferred Knowledge/Experience:
- Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas.
- Previous leadership experience an advantage.
- Knowledge of GMP and validation of systems essential.
- Proven experience working on Aseptic fill finish team an advantage.
- A good knowledge of Health and Safety Systems and Environmental Control Systems is an advantage.
- Proven experience participating in regulatory inspections.
Additional information:
- This is a 23-month fixed term contract position.
- Position is based in Tralee – Ireland.
- This position requires you to be 100% on site/in the office.
What We Offer:
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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