About This Job To provide technical support and expertise to Manufacturing Operations and other departments (QA, QC, validation, engineering, Health & Safety, environmental departments) to ensure effective investigation / root cause analysis, risk analysis and implementation of robust corrective actions, thereby supporting efficient production operation, manufacturing schedule adherence and batch release.To promote life cycle management of products in the EU area as the functional lead to represent CBTL.To communicate with CBTL to share technical knowledge and achievement for further collaboration.To provide technical expertise for the possible new product development and introduction to the Dublin Plant.To ensure compliance of the function with all internal and external regulatory, legislative, and statutory requirements.
To provide strategic value add operational input and direction in support of the plant's technical operational activities and requirements, including support to projects / initiatives in the manufacturing areas.To support the Lead Pharma Manufacturing Technical Operations DP in the provision of operational expertise in all areas relating to the role.To collaborate with Pharma Manufacturing Technical Operations DP in the execution of duties assigned as part of the role.Actively support the sites Operational Excellence Programme and ensure it is embedded in all aspects of production operations.Essential Knowledge & ExperienceEducated at a minimum to degree level in a scientific discipline.
Education to MSc or Ph.D. level would be preferable.Minimum of 5 years working in a process support and/or development function in a cGMP environment or process development at CMC labsHas a broad GMP and technical knowledge to oversee emerging issues.Familiar with TrackWise or other quality management systems desirable.Strong evidence of problem-solving skills.Knowledge of technology transfer is preferred but not a requirement.Good communication skills.Japanese language skills for regular communications with CBTL colleagues.Preferred Knowledge & Experience MSc or Ph.D. level in a scientific discipline.
Additional information This position is based in Astellas Ireland Co. Ltd., Dublin Plant and will require on-site office and laboratory-based work.
Collaborates regularly in Japanese with CBTL colleagues.
Please note our closing date for this role will be Sunday 15th September.At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.Our expertise, science and technology make us a pharma company.
Our open and progressive culture is what makes us Astellas.
It's a culture of doing good for others and contributing to a sustainable society.Delivering meaningful differences for patients is our driving force.
We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.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.Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.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.