Process Scientist - Offaly
I'm currently recruiting for a number of Process Scientists to join a busy team in Tullamore, Co. Offaly.
- To support the development, optimisation, scale-up and validation of all upstream steps in a monoclonal antibody production processes.
- Work with external partners to provide the necessary technical support for successful completion of projects including the transfer of processes into the facility.
- Strict adherence to GMP, working in a cleanroom environment and executing batch records.
- Support the writing and updating of Batch Manufacturing Records, SOPs, and other quality documents required for GMP manufacture.
- Provide hands-on support for all manufacturing activities including buffer / media preparation, cell culture and bioreactor process steps.
- Provide technical input and support writing of technical reports required for regulatory purposes
- Participate in Quality and Safety regulatory audits and completion of deviations and investigations into non-conformances.
- Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices.
- Manufacture products using cell culture techniques
Qualification and Experience:
The successful candidate would meet some or all of the criteria below;
- Sc. or B.Sc in Chemical/Biochemical Engineering or related Biological Sciences with ³ 1 years of industrial experience preferably.
- Basic mammalian cell culture experience including thawing, culturing, cell counting.
- Experience using SAP and Trackwise/ETS would be highly advantageous.
- Hands on experience of bioreactors such as WAVE and Xcellerex or equivalent systems desirable.
- Experience in scale up of bioprocesses from bench scale to large scale.
- Working in a controlled regulated environment e.g. GMP/GLP
- Knowledge of analytical methods required for cell culture/protein characterisation.
- Experience with deviation investigations and CAPA implementation would be highly advantageous.
- Knowledge of key suppliers of process materials and equipment including disposable systems.
- Excellent verbal and written communication skills. Ability to maintain very clear records of work completed.
To apply, please upload your CV to the link provided below.