Vienna, Vienna, Austria
I am a biochemist and molecular biologist by training, providing 4.5 years of industry work experience in GMP compliant Quality Management and QC analytics and 10 years of work experience in production of recombinant biomolecules and their biochemical and molecular biological analysis in an academic research setting. As Quality Management Expert and Teamlead my focus is to assure GMP-compliant manufacturing of APIs and Biopharmaceuticals. Currently, I am adapting, establishing and maintaining quality systems due to transition from chemical API synthesis to biopharmaceutical fermentation. I am representing the quality system during national and international inspections, as well as external and internal audits. I am responsible for review and approval of master batch records, executed batch records and batch-specific analytical documentation. I am QM lead of environmental monitoring, trend analysis, quality risk management and document review. I provide additional expertise in deviation and change control management, implementation of CAPAs, document life cycle management, development, transfer and validation of cell culture based bioassays and technology, lab-scale production and purification of recombinant proteins and characterisation of protein interactions in vitro and in vivo in bacterial, mammalian and plant systems. I contribute to qualification of utilities, upstream and downstream process validation, cleaning validation and analytical method validation. I enjoy teaching, training staff, and helping others to develop. I invite you to reach out and to connect!
Adapting and maintaining the company quality system. Representing QMS during national and international inspections and audits. Lead auditor for contract analytical services. Establishing executed batch record review and release processes. Lead review and approval of process validation and cleaning validation. Reviewing executed batch records and analytical documentation. Establishing cleanroom environmental monitoring program and trend analysis. Establishing environmental monitoring reports. Lead review and approval of periodic and batch-specific monitoring reports. Establishing periodic review and audit trail review processes.
Quality risk management lead. Lead review and approval of analytical method validation. Provided guidance in validation of bioassays and microbiological method validation. Performed internal audits (company-wide) and external audits (contract analytical services). Coordinated and represented quality management during customer audits.
Adapted the company quality system during transition from organo-chemical API synthesis to biopharmaceutical fermentation. Managed document life cycle. Reviewed qualification documents. Managed Deviations, CAPAs and Change Control activities company-wide.
Cell Culture Based Bioassays Division Interfaced between External Customers, PM, QC Analytics and QA divisions. Planned, initiated and supervised Batch Release and Stability Study-related QC analytic activities. Supervised and performed transfer of validated cell-based bioassays (SME, Project Lead and Validation Team Lead).
Cell Culture Based Bioassays Division Conducted and supervised development and transfer of cell culture based bioassays including data analysis and report generation. Inititated and participated in quality-relevant processes (DEVs, CAPAs, Change Control). Participated in equipment qualification and computerised systems validation. Supervised and performed transfer and validation of 8 pre-clinical virus-based bioassays (SME, Project Lead and Validation Team Lead).
Department of Chromatin, RNA and Chromosome Biology Assoc. Prof. Dr. Peter Schlögelhofer Visualised meiotic DNA strand invasion and strand exchange via advanced light microscopy, biochemically characterised DNA strand exchange proteins.
Center for Anatomy and Cell Biology Univ.-Prof. Dr. Michael Jantsch Established a new research division at the Center of Anatomy and Cell Biology. Interfaced between scientific and administrative personnel. Managed and assisted several research labs. Served as single point of contact for external companies. Responsible for supply chain management. Produced and purified recombinant proteins for interaction studies. Designed and conducted cell biological and biochemical experiments. Trained Bachelors, Masters and PhD candidate students.