
Fabian Baiz
Skills
Timeline
Professional experience for Fabian Baiz
Quality Assurance Consultant in Development (NCE/NBE) at Boehringer Ingelheim Pharma GmbH & Co. KG on behalf of FERCHAU GmbH (Ulm, Germany) - QA für Equipment Qualifizierung in der analytischen Entwicklung - Review und Freigabe von LeVA Dokumenten - Key User & Quality Approver für TrackWise GoTrack (Change Control) - Review & QA-Freigabe von technischen Änderungen (Change Control) in der analytischen Entwicklung - Review & QA Freigabe von Kalibriervorgabelisten (KVLs) - Review von SOPs & Betriebskonzepten
- 11 months, May 2019 - Mar 2020
Production Technican/Associate for Gene Therapie
Kiadis Pharma
Structure, Development and Establishment of an aseptic ATMP Production site under GMP conditions in cooperation with PD, QA and QC in clean room conditions (class A/B) - Implementation & optimization of a production process - Writing, revision and optimization of GMP documents - Support in the investigation of quality defects - Responsible for equipment, calibration/maintenance and qualification (FMEA, DQ, IOQ, PQ) - Part of the quality assurance system (deviation management, CAPA, Change Control)
- Method development & establishment for spectroscopic imaging incl. development of suitable preparation techniques for biological material - Establishment/development of imaging and spectroscopic methods for specific diagnostics and correlative analysis methods (RAMAN, MALDI Imaging, light/fluorescence microscopy, electron microscopy) - Investigation and characterization of particles via scanning electron microscopy and elemental analysis - Studies under GMP/GLP conditions
- Method development & establishment for spectroscopic imaging incl. development of suitable preparation techniques for biological material - Establishment/development of imaging and spectroscopic methods for specific diagnostics and correlative analysis methods (RAMAN, MALDI Imaging, light/fluorescence microscopy, electron microscopy) - Investigation and characterization of particles via scanning electron microscopy and elemental analysis - Studies under GMP/GLP conditions
Department/Group: Analytical Development/Analytical Technologies, Nonclinical Drug Safety/Pathology Title of the thesis: Application of Raman spectroscopy in drug development Methods: Raman spectroscopy, IR spectroscopy, light microscopy, filtration, design of experiments, data analysis
Department/Group: Analytical Development/Analytical Technologies, Nonclinical Drug Safety/Pathology, Analytical Development Biologics/Services & Infrastructures Title: Establishment of Confocal Raman Spectroscopy for Pharmaceutical Development Methods: Raman spectroscopy, light microscopy, design of experiments, data analysis
* 20% Employment - Creation of a scientific database for the compilation of dossier documents (EndNote) o Creation of the database from literature o Optimization/adjustment of the program (document code and quality attributes) o Literature research - Creation of a database to manage product-specific reports - Creation of graphics (in Origin) for the creation of approval documents - Revision of specific approval documents with a view to language, content, references and formatting
Educational background for Fabian Baiz
- 2 years and 1 month, Sep 2018 - Sep 2020
Biopharmaceutial/Medical-Technical Sciences (M.Sc.)
Hochschule Biberach - Biberach University of Applied Sciences/University Ulm
- part-time master's programme - 70 % of the theoretical modules have already been successfully completed
- 4 years, Sep 2013 - Aug 2017
Pharmaceutical Biotechnology
Hochschule Biberach - Biberach University of Applied Sciences
Chemistry, mathematics/statistics, physics, bioinformatics, biotechnology, biochemistry, physiology, cell biology, microbiology, molecular biology, genetic engineering, cell culture technology, protein biochemistry, process engineering, sterile and clean room technology, GMP, protein analysis
- 2 years and 11 months, Sep 2009 - Jul 2012
Pharmazie/Biotechnologie
Apprentice: Pharmaceutical Technician
Training to become a pharmaceutical technican (skilled worker) which is certified by the Chamber of Industry and Commerce. Training assignments outside the training were completed in Validation & Qualification, Biopharmaceutical Drug Production (USP & DSP) and Pharmaceutical Development.
Languages
German
First language
English
Fluent
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