Reporting through the site manufacturing and technology head and based at the Dublin site.
• Support the design, construction and qualification of upstream & downstream equipment at site through to technology transfer and commercialization.
• Support establishment of the commercial process and routine manufacturing by:
Supporting experimental design, execution, data analysis and interpretation.
Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
Supporting deviation management.
Supporting change control prioritization and implementation.
Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.
• Applying LeanSixSigma tools 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.
• Serving as a key member during internal audits and external inspections/audits.
• Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc.)
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
• This role may require shift work support after the facility startup phase is complete.
• With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience.)
• A minimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company.
• A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• Strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams.
• The ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
• Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
• Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software.)
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
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