Process Scientist Opportunity
1 day ago
The Technical Services team is seeking an experienced Process Scientist to support commercial manufacturing and technology transfers.
You will be a key member of the high-performing technical services team, responsible for:
- Supporting commercial manufacturing to meet commercial requirements, including investigations, process robustness, and process improvements.
- Scaling up processes to the manufacturing facility.
- Performing, presenting, and executing facility fits, mass balance generation, equipment sizing, gap assessments, and mitigation of operational challenges foreseen to ensure an equivalent process is transferred to the manufacturing facility.
- Providing independent decision-making for strategic input into facility and equipment design.
- Preparing, reviewing, and executing technology transfer protocols, supporting documentation, manufacturing batch records, design of experiments, and at-scale process trials to deliver an efficient technology transfer.
- Authoring and reviewing responsible sections of regulatory dossiers, including health authority query responses.
- Partnering with the management and technical team to identify best practices, technical transfer efficiencies, and optimisations during technical transfer.
Requirements
A minimum of 3-6 years of process development/late-stage characterisation and technical transfer/technical services experience in single-use systems is required.
The ideal candidate should have demonstrated history and in-depth knowledge of technical transfer, facility fit, equipment sizing, and mass balance generation for clinical/commercial manufacture.
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