Website TPM05425
Summary:
Our client, a biopharmaceutical located in Dublin, is looking for a Bioprocess Scientist. The ideal candidate will be responsible for supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations.
Responsibilities:
- 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.
Qualifications & Experience:
- Master’s degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
- 1 to 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
To apply for this job email your details to lara.miranda-pinto@tandempm.ie.