Steffi Pann

• Author and manage Scientific Advice submissions with regulatory authorities • Establish and maintain an electronic Quality Management System (eQMS) • Develop and implement risk assessment strategies for manufacturing and quality processes

Field: GMP Production • Performed GMP manufacturing of regulatory T cells and CAR T cells • Authored and reviewed SOPs • Reviewed and authorized release of GMP documentation ensuring compliance with regulatory standards

Field: Technical Development • Optimization of CAR-T cell product manufacturing (Planning and analysis, work distribution across internal team, non-viral transduction, automation) • Writing of study proposals and development reports • Support with regulatory issues, e.g. Scientific Advice, ISO 13485, risk analysis, FMEA • Cross-functional collaboration with the engineering team for hardware, tubing set and process development • Statistical evaluation of data • Management of apheresis supply for the entire development team

Field: Technical Development • Planning, preparation and execution of R&D experiments for in-house selection technology platform • Analysis and presentation of R&D data in cross-functional teams • Cell biological analytics (e.g. Flow Cytometry) • Preparation of work instructions and SOPs as well as technical training for new employees in the use of cell selection and other laboratory equipment • Development, creation and continuous improvement of a detailed documentation structure of all tests performed and data collected within the team • Organization and management of daily lab routine

Field: Technical Development • Preparation, execution, analysis and discussion of R&D experiments for in-house selection technology platform • Organization, coordination and management of stocks and orders of the R&D department

Field: Esophageal cancer • Support of daily lab routines, e.g. Flow Cytometry of isolated murine immune cells, immunohistological staining • Administrative and organizational work in the lab • Establishment of work instructions for experiments

Field: Antibody Discovery and Characterization Unit • Establishment of new assays • Development of new protocols to optimize work processes and costs • Preparation of data reports, reporting of project progress and timelines

Master thesis: Activation of dendritic cells and lymphocyte populations - comparison of two mouse strains

Bachelor thesis: Aktivierung von Immunzellen außerhalb des Versuchstieres