Senior Process Scientist
Permanent _ Full time
Our client a main Pharmaceuticals 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. They are currently expanding their product portfolio and will transfer mammalian cell culture processes into site.
They are seeking a Senior 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).
- Supporting the technology transfer of manufacturing processes into a Mulit-Product facility including representing site at key internal and external tech transfer meetings.
- 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.).
- Capture all the aspects of the existing process and equipment to ensure that an equivalent process is transferred to the plant
- Technology Transfer, including Gap Analysis and Process Transfer Risk Assessment
- Execute requisite process trials to facilitate transfer as required (bioreactor kLa studies, media make-up & hold, , media simulations, etc)
- Define the Process Definition (Description), including Bills of Materials, Raw Materials and Consumables
- Develop process validation protocols and lead their execution on the floor in conjunction with Operations. Generate process validation summary reports and associated filing summaries.
- Ensure the process automation meets the requirements of the process
- Process input to equipment specification process, including equipment sizing, specification of key components, verification documentation and process instrumentation ranges.
- Execute water, demonstration and process validation batches
- Drafting of filing submissions and assist with inspection readiness activities including preparation of playbooks.
- Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC
- Lead major process investigations as requested and support the implementation of CAPAs.
- 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 technology
- Knowledge of technology transfer
- Demonstrated aptitude for technical learning and problem solving.
- Strong evidence of problem solving skills
- Good communication skills
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 biotechnology in the curricular.
Please send your CV to Aoife at email@example.com or call us on 01-4569899