RP / FvP delegate -> Batch Record Review and and Final Drug Product releaseQuality Oversight -> Deviation, CAPA and Change Management, Gemba Walks

- Ensure uninterrupted and GMP-compliant operation of sterile drug product manufacturing- Review key performance indicators (KPIs) and implement improvement measures- Handle deviations, complaints, and CAPAs as the Deviation Owner- Conduct Multisite Assessments and lead Root Cause Analysis (RCA)- Implement new and improve existing manufacturing processes, ensuring compliance to current and updated applicable regulations- Manage / Lead projects and changes as project and change owner- Contribute to the launch of new products- Apply LPS tools and provide expertise in problem-solving- Deliver trainings within the process unit- Create and maintain the GMP document landscape as author and owner- Act as a Subject Matter Expert (SME) during inspections and audits- Represent the process unit in relevant meetings and gremiums (global, planning, etc.)- Provide support in Quality Risk Management (QRM) as an SME

Supporting the chapter Manufacturing Compounding & Visual Inspection in various tasks, such as cGMP-related topics, SOP management, deviation management and investigations (UPEs and PEs), audit and inspection-related topics, day-to-day cGMP-manufacturing topics (planning and E2E-support), cross-functional projects with QA, QC, Logistics & Supply Chain, or Filling.

Title: "Discovery, generation, and Characterization of Novel Antibody Fusion Proteins for Cancer Immunotherapy"Final Grade: 5.75 / 6.00The aim of this project was to discover and generate a novel antibody against the NKG2D receptor on natural killer cells. This was done using antibody phage display technology and performing affinity maturation. An anti-NKG2D antibody, previously generated by Dr. Sheila Dakhel, was used as the starting point for the affinity maturation. I carried out the protein production, purification, and quality control steps (SEC, SDS-PAGE, etc.) for the antigen (NKG2D), as well as the potential binders. Together with my supervisor we performed the phage display affinity maturation protocol and all required preparations / experiments that had to be done in advance. Lastly, I performed several characterizations on the novel generated antibodies, such as KD determinations using SPR (Biacore) or ELISAs, as well es multiple cell based assays and FACS experiments (binding, etc.). The project was successful and we managed to isolate a novel antibody with increased affinity compared to the original antibody.