Dr. Edina Csaszar

Manufacturing Science and Technology; Process Development mRNA; Development and qualification of analytical procedures for in-process control and final analytics; Team lead of process engineers and scientists

Regulatory compliance of analytical method validation activities. Compilation of regulatory documentation of CMC activities (IMPD Module 3). skills: Pharmaceutical quality management, GMP, validation, lateral leadership, compilation of regulatory documents (CMC, IMPD Module 3), liaise with authorities for submission of regulatory documentation

Management of manufacturing activities Responsible for regulatory compliance of manufacturing activities. Manufacturing of active substance, formulation and aseptic filling of final drug product. Manufacturing of analytical reference material and critical reagents. skills: GMP, regulatory compliance, aseptic filling, downstream processing

Regulatory compliance of GLP activities. Improvement of the quality management system of the Test Facility. Preparation and conduction of authority inspections. Instruction and supervision of employees concerning regulatory compliance of conduction and documentation of GLP activities.

Regulatory compliance of the documentation of manufacturing activities. Manufacturing of active substance, formulation and aseptic filling of investigational medicinal products for Phase I and II clinical trials of active immunisation therapies. Skills: EU GMP clean room A/C/D; downstream processing, GMP

Release and stability testing of active substance and drug product formulations Supplier selection and qualification for external analytical services Presentation of data, preparation of internal and external reports and regulatory documents (IMPD/IND Module 3) Preparation of responses to regulatory agency requests and preparations for regulatory scientific advice / IND meeting skills: quality control, electronic document management systems, audit, supplier qualification

Development of analytical chemistry methods for protein analysis; identification of proteins, qualitative and quantitative analysis of post translational modifications by LC-MS/MS. Participation in the development of analytical instruments; ß-testing of mass spectrometry and chromatography hardware and software. Coordination of the Mass Spectrometry Facility of the Max F. Perutz Laboratories; responsible for user and data management, financial management and consulting. Undergraduate teaching activities.

Protein chemistry; Mass spectrometry; Chromatography

Analytical chemistry/ Mass spectrometry - thesis; Cell Biology / Immunology