We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
1.Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up
2. Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment
3. Execute requisite process trials to facilitate transfer as required (bioreactor kLa studies, media/buffer make-up & hold, cleaning cycle development, column packing, preservative flush-out, media simulations, etc)
4. Define the Process Definition (Description), including Bills of Materials, Raw Materials and Consumables
5. Develop process validation protocols and lead their execution on the floor in conjunction with Operations. Generate process validation summary reports and associated filing summaries.
6. Ensure the process automation meets the requirements of the process
7. Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges.
8. Execute water, demonstration and process validation batches
9. Drafting of filing submissions and assist with inspection readiness activities including preparation of playbooks.
10. Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC
11. Lead major process investigations as requested and support the implementation of CAPAs.
12. Provide technical training on process and technology areas as required by the project.
1. A minimum of aB.Sc., B.E. orM.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or a Biotechnology or Industrial Chemistry Degree
2. Experience working in a cell culture manufacturing process or process development environment.
3. Familiarity with the operation of cell culture and/or purification technology
4. Experience of process and cleaning validation requirements and execution for GMP biological production
5. Knowledge of technology transfer is preferred but not a requirement
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480