- Drive technology transfers and clinical manufacturing activities such as process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training and technical support.
- Triage operational challenges and deviations with internal stakeholders and Point-of-Care Manufacturing units (PMUs) to ensure compliance and qualification/batch progress.
- Lead/support operational activities through the stages of technology transfer and continued operations, as well as training and continuous improvement activities.
- Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports.
- Perform data trending and analysis for Key Performance Indicators related to operational performance.
- Support and lead initiatives for equipment, facility and engineering workstreams related to manufacturing at PMUs and interact with external stakeholders and vendors where required to drive improvements.
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Process Engineer PoC Operations EU - Leiden, Nederland - Galapagos
Beschrijving
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We're in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The 'make-it-happener'.
Scope of the role :
For our Cell & Gene Therapy organization in Leiden/NL, we are seeking a highly motivated (Senior) Process Engineer to join the Point-of-Care Manufacturing team (PoC). This team provides technical-operational expertise to the GMP operations at decentralized point-of-care manufacturing units in Europe. As our (Senior) Process Engineer, you are a subject matter expert on the manufacturing process during operations and Technology Transfer activities of automated CAR-T, helping to drive operations from site selection through clinical/pivotal/commercial readiness.
Your responsibilities :
As our (Senior) Process Engineer, you will report to the Manager/Associate Director PoC Operations.
