We are seeking a highly skilled professional to join our team in a challenging opportunity with a leading biopharmaceutical organization based in Dunboyne. This role is ideal for individuals who are looking to develop their skills in a dynamic multinational company.
1. Collaborate with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs.
2. Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
3. Manage new program introduction schedules to ensure tasks are executed on schedule and right-first-time.
4. Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
5. Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
6. Employ an innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
7. Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
8. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
9. Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
Requirements
* Minimum of 3 years of work experience in the pharmaceutical or biotech industry
* Bachelor's degree in Engineering, Biotechnology, Chemistry, or related field.
* Technical knowledge with Biologics drug substance upstream and downstream operations or process development.
* Understanding of the principles and activities of New Product Introduction NPI/Tech Transfer
* Familiarity with the use of Automation systems in a manufacturing Process such as DeltaV, MES, eVal as well as business tools such as Power Project and Power BI.
* Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
This role offers a fantastic opportunity to grow professionally and personally. If you are interested in this position, please contact us for further information.