Our client, one of the largest Biotech facilities in the world is seeking a Process Scientist to work within the Drug Substance Technical Services Team. This is an ideal development opportunity to join a dynamic team who provide process science support to the ongoing requirements of the manufacturing area and support process transfer projects into the manufacturing suite. The process scientist is responsible for providing technical support to the operating unit ensuring that the processes are robust, appropriately validated and run to maintain that validated state.
- This is a non-laboratory-based role, providing SME support to the protein drug substance manufacturing facility
- Support major investigations, including preparation of process impact assessments;
- Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends;
- Support introduction of new raw materials or consumables and assessment of Supplier Change Notifications (SCN’s);
- Execute Annual Product Quality Reports (APQR) and process capability analysis on commercial processes, on a periodic basis;
- Cleaning validation execution, including periodic re-validation;
- Implementation of process improvements (yield / robustness / cycle time / cost reduction);
- Process validation execution in support of major process changes;
- Strong understanding of 6-sigma principles;
- Regulatory inspection support and close-out of regulatory follow-up measures;
- Technology transfer of new processes or process changes;
- Process equipment design, including development of user requirement spec;
- Introduction of new technology, including process analytical technology (PAT).
- Minimum qualification of a B.Sc./M.Sc. or higher qualification in chemistry, biotechnology or a related discipline;
- Minimum of 2 years’ experience in the pharmaceutical / biopharmaceutical industry
- Strong background in mammalian cell culture, protein purification or validation;
- Strong evidence of problem-solving/trouble-shooting skills.
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email firstname.lastname@example.org
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