Quality , Science, Pharmaceutical & Food
Process Sciences Specialist – Cell Culture
- Dublin North
PE Global is currently recruiting for a Process Sciences Specialist for a client site in Dublin –
Reporting through the site manufacturing and technology head and based at the Biotech Dublin site, the Specialist Process Sciences responsibilities include, but are not limited to the following:
- 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 LeanSixSigma 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.
What skills you will need:
- A master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
- 0-3 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, marked for the attention of Audrey
firstname.lastname@example.org or 00353 21 4297900