Process Scientist
- Dublin
- Permanent
- Full-time
- Support commercial manufacturing to meet commercial requirements including investigations, process robustness and process improvements.
- Scale up of mammalian cell culture processes from bench and pilot scale to a pilot & large-scale manufacturing facility.
- Perform, present and execute facility fits, mass balance generation, equipment sizing, gap assessments and mitigation of operational challenges foreseen to ensure an equivalent process is transferred to Grange Castle
- Provide independent decision making for strategic input into facility and equipment design
- Prepare, review & execute technology transfer protocols, supporting documentation, design of experiments and at scale process trials to deliver an efficient technology transfer
- Author and review responsible sections of regulatory dossiers including health authority query responses
- Partners with the management and technical team to identify best practices, technical transfer efficiencies and optimisations during technical transfer.
- Develops and maintains effective working relationships with other division groups supporting technology transfer, validation and process support.
- Minimum of 3 - 6 years of mammalian cell culture process development/ late-stage characterisation and technical transfer / technical services experience in stainless steel and/or single use facilities
- Demonstrated history and in-depth knowledge of cell culture scale up practices, technical transfer, facility fit, equipment sizing and mass balance generation for clinical/ commercial manufacture
- Knowledge and experience of process validation strategies, studies and requirements
- Knowledge of regulatory submissions and response of queries from health authorities
- In depth knowledge of cGMP regulatory requirements related to the design and control of drug substance processes
- High technical capability, interpret complex data, problem solving and technical learning.
- Promote information sharing and excellent interpersonal skills
- Capability of working in a multi-disciplinary team environment to tight timelines
- Effective communication, planning and organisation skills to deliver documentation.