Johann Weber

• Planning, coordination, organization and execution of production campaigns in 1,000 L and 2,000 L Single-use bioreactor plants for the production of recombinant proteins under GMP conditions • Technical management of production teams • Scale-up / process transfer from R&D to production • Establishment, review and training of GMP documentation • Support with technical and project-specific issues during audits and inspections

Ulm University Hospital; Surgery Center; Department of General- and Visceral Surgery Methods: • Radioactively labeled in vitro kinase assays • Expression and purification of 6xHis- and GST-tagged fusion proteins via FPLC • 2-D phosphopeptide mapping • Gibson Assembly, SDS-PAGE, Western Blot

Methods: • Support of project managers in the preparation and execution of clinical studies (early phase I/II) according to ICH-GCP • Preparation and quality control of study documents for ethics committees and regulatory authorities

Title: Conception of a specification for the qualification of employees in manual visual inspection according to the US Pharmacopoeia Chapter <1790> Methods: • Planning and elaboration of a specification of test sets for the visual inspection of parenteralia • Statistical evaluation of production key figures within the visual inspection • Implementation of process and risk analyses under GMP requirements

Development/Support of visual inspections (documentation systems) of aseptically pre-filled application systems (syringes, cartridges, vials) Department: Pharmazeutische Produktion/Produktionssysteme Methods: • Implementation of formal tests within the scope of process validation under GxP requirements • Planning and implementation of employee training courses at pharmaceutical production on site • Target/actual analysis and cause study of process deviations in aseptic filling

Development and support of biotechnological online learning modules for students. Unterstützung im Rahmen des e-Learning Projektes "eLearning@Biologie in Bayern (eLaBB)", Erarbeitung von eLearning-Einheiten im biotechnologischen Umfeld.

Focal points: Bioprocessing, Pharmaceutical Production, Quality Assurance, Drug Registration, Stem Cells and Regenerative Medicine, Inhibitors and Therapeutics

Focal points: Bioprocess Engineering, Bioanalytics, Biocatalysis, Food and Pharmaceutical Technology, Molecular Biology