Process Scientist Tech Transfer
Department: Grange Castle Technical Services
Position Reports to: Tech Services Manager
Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant is situated on a 90-acre site in South Dublin. The site manufactures Biopharmaceuticals and Vaccines – with multiple manufacturing technologies, including; large-scale mammalian cell culture, protein purification, vaccines conjugation, and aseptic syringe filling. We are currently expanding our product portfolio and will transfer a new mammalian cell culture process from a CMO.
We are seeking a Process Scientist, whose role will be:
• Key member of the transfer team, working within the site Technical Services supporting the multiple transfer of the mammalian cell culture processes (Upstream and Downstream). Estimate duration of the tech transfer project is 3 years.
• Responsibility for the technology transfer of the process into a Mulit-Product Manufacturing facility (Upstream and Downstream) within Grange Caste including representing site at key tech transfer meetings with the CMO.
• Provide process science, manufacturing technology and validation support for the process tech transfer of cell culture processes into the existing Drug Substance facility
• Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.).
Full Time - The role may require flexibility to travel to process donating sites in US/Europe and to project meetings away from site.
1. Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up at Grange Castle
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.
- Experience working in a cell culture manufacturing process or process development environment.
- Familiarity with the operation of cell culture and/or purification technology
- Experience of process and cleaning validation requirements and execution for GMP biological production
- Knowledge of technology transfer is preferred but not a requirement
- Demonstrated aptitude for technical learning and problem solving.
- Strong evidence of problem solving skills
- Good communication skills
Our Culture is hugely important to us at Grange Castle. It is the embodiment of how we behave, act, lead and engage with people every day. Our vision is, together, deliver life changing medicines to our patients. Our success is achieved through the commitment, engagement and excellence of all our colleagues.
A minimum of a B.Sc., B.E. or M.Sc./M.Eng. Degree in Biosciences, Chemical Engineering or equivalent; equivalent defined as a Biotechnology or Industrial Chemistry Degree with a large element of engineering fundamentals as applied to biotechnology in the curricular.
Interested candidates, please send your CV to John.Toomey@cpl.ie