Biotech Associate – 23 Month Fixed Term Contract
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:
As a Biotech Associate, you are responsible for executing activities within the department to produce pharmaceutical drug products in a cleanroom environment, including aseptic filling and lyophilisation processes, in a timely and efficient manner. You will ensure full compliance with all internal policies and external regulatory, legislative, and statutory requirements. Under the direction of the Team Lead, you will perform assigned duties and contribute to the overall effectiveness of the team. Additionally, you will provide value-added input to support plant operations and various initiatives or projects within the manufacturing areas. The individual also actively participates in the site’s Operational Excellence Programme, contributing to continuous improvement efforts.
Responsibilities:
- Manufacturing Operations: Perform all required tasks in the cleanroom (e.g., Grade A – CNC) to manufacture pharmaceutical products, ensuring adherence to safety, quality, and efficiency standards.
- Compliance & Documentation: Ensure compliance with cGMP, ISO 14001, Health & Safety, and site policies; contribute to the preparation and review of manufacturing documentation.
- Data & Systems Management: Accurately input and extract data from computerized systems, maintaining data integrity and compliance with site standards.
- Problem Solving & Investigations: Troubleshoot equipment and material issues to minimize downtime and ensure compliance; participate in investigations and cross-functional collaboration.
- Training & Teamwork: Complete required training, deliver training when needed, and promote strong teamwork and a culture of safety throughout the organization.
- Project & Reporting Support: Support operational projects, validation, and new product introductions; report regularly to the Team Lead and communicate potential issues promptly.
Essential Knowledge & Experience:
- Customer & Strategic Focus: Committed to delivering value to patients by meeting/exceeding customer expectations and aligning personal/team goals with Astellas’ broader strategy. Proactively seeks feedback and balances strategic vision with operational execution.
- Innovation, Results & Change Orientation: Embraces change with a continuous improvement mindset, taking ownership for enhancing processes and outcomes. Demonstrates strong decision-making, attention to detail, time management, and effective use of IT systems.
- Collaboration & Communication: Works effectively across functions, values diverse perspectives, and communicates clearly. Shares knowledge, builds consensus, and adapts approaches to strengthen teamwork and inclusion.
- Growth, Leadership & Integrity: Acts as a role model of ethical behavior and compliance, promotes learning and development, and seeks regular feedback to improve personal and team performance.
Education:
- Minimum Level 6 in Engineering/Science discipline or equivalent is required
Preferred Knowledge/Experience:
- Technical & Regulatory Knowledge: Experience in cGMP environments, aseptic fill-finish operations, audits, and regulatory compliance, with familiarity in GMP computerized systems and problem-solving in similar settings.
- Process Improvement & Problem Solving: Demonstrates strong analytical skills and a commitment to continuous improvement, with Lean Six Sigma (Yellow Belt or higher) considered an advantage.
- Communication & Interpersonal Skills: Excellent verbal and written communication skills, with strong interpersonal and organizational abilities.
- Adaptability & Teamwork: Works effectively independently or in teams, adaptable to shifting priorities, and open to new ideas and approaches.
Additional information:
- This is a 23-month fixed-term contract position
- This position is based in Tralee, Ireland
- This position requires you to be 100% on-site / in the office
- Willingness to undertake international travel
- Required to work weekends and shift work as per business needs
- Willing to work additional hours and/or travel as required by the business.
- Flexibility for some out-of-hours cover is a part of the role.
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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