Scientist USP Development (Iceland) Reykjavík Iceland,
Most important tasks of the job:
- Develop robust upstream process to target product titre and quality specification
- Carry out upstream development in flasks and bioreactor understanding mammalian cell behaviour to improve product yield and impurity profile
- Scale up of fermentation from flask to 100 L in-house, process-ready for transfer to 1000 & 2000L bioreactor in production
- Troubleshoot upstream related issues as required
- Perform QC analysis on in-process samples to monitor impurities
- Assist in downstream process development for cross flow filtration
- Record experiments, analyse results, write reports and present them
- Support technology transfer of purification process to production including reviewing BMRs transferring skills and monitor technology transfer, engineering and GMP runs.
- Perform routine fermentation and clarification to generate material for downstream process development and to support internal/external pre-clinical development and testing
- Personal performance and goals:
o Continuous training to increase know-how to meet new requirements of regulatory bodies as well as technical developments
Prerequisite: Scientist USP Development position is based at the manufacturing site (Iceland).
Organisation Structure: Scientist USP Development reports to the Director, Research and Development.
Education: Degree / post graduate degree in Biochemistry, Biotechnology or related Biological Sciences.
Languages: English (fluent)
Experience: Experience of working in process development environment (i.e. fermentation or chromatography purification) making media, buffers, performing analytical assays, setting up seed cultures, etc.
Knowledge of upstream processing in the development of mammalian fermentation processes, i.e. media development and implementing feed strategies to achieve high cell density cultures to obtain high product yields.
Industrial experience in developing processes to the level of current Good Manufacturing Practice would be advantageous.
Adaptable and willing to take on diverse tasks within a small team.
Knowledge: Experience of working in a manufacturing team is essential, as part of a process development environment. Although not essential, industrial experience in developing processes to the level of current Good Manufacturing Practice would be advantageous. Candidates must be adaptable and willing to take on diverse tasks within a small team.
Please submit your application by November 15th at the latest and send us your CV in english.
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