Nóra Dr. Szendi

• Supervising and coordinating the plant scale development of biotechnology drug products at the production facility
• Overseeing CDMO production activities, including regular collaboration and meetings with external partners
• Leading technology transfer and scale-up activities
• Managing the development of analytical methods, including in-process control, functional and container closure integrity tests
• Providing technological support for commercialized production, managing the life cycle of drug products and maintenance of manufacturing recipes in the SAP system
• Communicating project expectations to team members through regular meetings, while delegating tasks and actively engaging them in the process
• Ensuring compliance with industry standards and regulations by maintaining strict adherence to established guidelines during project execution
• Participation in internal inspections and regulatory audits
• Continuous collaboration with consultants to enhance manufacturing processes and ensure GMP compliance

Coordination of development projects and management of plant scale productions requiring strong organizational and time management skills to meet tight deadlines.

• Development of biotechnology drug products
• Overseeing productions from engineering runs to validation batches
• Preparation of technology related documents such as batch records, optimization plans and reports, technological risk assessments
• Preparation of Extractable & leachable risk assessments for product contact materials, coordination of filter validation activities
• Participation in the investigation of batch deviations

• Supervision of dispensing and solution preparation of injectable drug products in a GMP environment
• Preparation of SOPs and production relevant documentations
• Coordination of cleanroom environmental monitoring
• Deviation management