Quality , Science, Pharmaceutical & Food
Scientist
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Contract
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CarlowIreland
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42017193
Desired Skills: Process Development,mammalian cell technology,biochemistry,cell biology,process modelling,technology transfer
PE Global is currently recruiting for a Senior for a leading multi-national Pharma client based in Dublin.
This is a 11 month maternity cover contract.
Role:
- Supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations.
- Supporting process improvement and troubleshooting with end-to-end product focus.
- Provide technical support investigations, new process introduction or change implementation in commercial manufacturing operations.
- Authoring and reviewing development operating procedures and technical reports.
- Supporting global regulatory submissions as needed.
- Applying Lean SixSigma tools in the Process Sciences group by:
- Securing continuity of an appropriate LSS/CEM level of knowledge.
- Facilitating problem solving & risk assessment (FMEA) projects/meeting.
- Making problems visible and strive for continuous improvement.
Requirements:
- A master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
- 3 years’ experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing).
- Experience in drug substance process development, process characterisation studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics and process modelling.
- Experience in executing experimental programs in the laboratory.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
- Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Knowledge of and experience in applying Six Sigma and Lean methodologies
- Desirable evidence of Continuous Professional Development.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Niamh on +353 83 2033710 or alternatively send an up to date CV to niamh.mcdonald@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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