13509 – Scientist – Process Sciences – Dublin Contractor

Responsibilities

• Supporting and executing experimental design, data analysis, and interpretation to resolve complex cell culture deviations.
• Supporting process improvement and troubleshooting with an 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/meetings. Making problems visible and strive for continuous improvement.

Minimum Qualifications and Experience:

• 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 modeling.
• 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