Dr.-Ing. Pascal Baumann

QA Operations Expert / Deputy Team Lead - QA Ops Laboratories bei Novartis Pharma, Stein AG

Germany

About

Experience

  • Novartis Pharma Stein AG - NTO Aseptics (9 yrs 8 mos)
    • QA Operations Expert/ Deputy Team Lead - QA Ops Laboratories
      Jul 2024 - Present · 2 yrs

    • Senior QC Specialist/ Deputy Team Leader - QC Microbiology
      Mar 2019 - Jul 2024 · 5 yrs 5 mos

      Lab coordination of microbiology labs in the field of microbiological environmental monitoring: Lab planning, organization and trouble shooting Processing of deviations, OOS and OOE Production unit support Preparation/ QA committee member of audits and inspections Trainings for operators and lab personnel Authoring and reviewing of SOPs, risk assessments (FMEAs), reports etc. Deputy Team Leader

    • Senior QA Specialist - QA Ops Aseptic Processing
      Nov 2016 - Feb 2019 · 2 yrs 4 mos

      Processing and decision of deviations Production unit support Preparation/ QA committee member of audits and inspections QA Oversight in aseptic manufacturing Trainings for clean room personnel Authoring and reviewing of SOPs, risk assessments (FMEAs), reports etc. Planning and evaluation of microbial environmental monitoring

  • Karlsruhe Institute of Technology - Biomolecular Separation Engineering (Prof. Hubbuch) (Greater Karlsruhe Area)
    • Project & Group Leader - Biopharmaceutical Research
      Sep 2015 - Nov 2016 · 1 yr 3 mos

      Organization and scientific/ financial supervision of a multi-site EU project (Horizon 2020) Organization and scientific supervision of industrial cooperation research projects Staff leadership qualification seminar (basic and deepened) Quality management in regulated research seminar (GLP, GMP, GCLP) Student lectures in “project management”, “biopharmaceutical downstream processing” and “biothermodynamics” Organization and tutoring of practical student courses in biotechnology Genetical safety level 1 (S1) project leader Safety officer for laboratories and offices and declared first aider Supervision and guidance for doctoral, diploma, master and bachelor students

    • Scientist/ Research associate (Doctorate) - Biopharmaceutical Research
      Jan 2012 - Sep 2015 · 3 yrs 9 mos

      Combined high-throughput process development (HTPD) in up- und downstream processing of biopharmaceuticals: Upstream process development - Sterile processing and organization of cryo cultures - Bacterial and yeast cultivations Downstream process development - Cell disruption (sonication, high pressure homogenization, chemical lysis) - Protein precipitation and crystallization - Aqueous two-phase partitioning systems (ATPS), inclusion body refolding - Preparative chromatography (LC, HPLC, UHPLC) High-throughput process development - Miniaturized high-throughput cultivations (BioLector system) - Miniaturized Tecan robot screenings (ATPS, protein precipitation, etc.) - Chromatography on robotic work stations (RoboColumns, PreDictor plates) Chromatography modeling - Mechanistic modelling (convection, diffusion, reaction type) - Data fitting and determination of model parameters (adsorption isotherm data etc.) Protein analytics - Gel electrophoresis and capillary gel electrophoresis (Caliper GXII system) - Analytical UHPLC chromatography (size exclusion, reversed phase, ion-exchange, hydrophobic interaction, affinity chromatography) - Enzyme-linked immune sorbent assay (ELISA) and Western Blotting - UV/Vis/Infrared spectroscopy and multi-variate data analysis of protein spectra - Development of product-specific assays (e.g. enzyme assays) Organization and tutoring of practical student courses in biotechnology Establishment of a genetical safety level 1 (S1) laboratory Genetical safety level 1 (S1) project leader Safety officer for laboratories and offices and declared first aider Supervision and guidance for doctoral, diploma, master and bachelor students

  • Industrial internship - Computitional Fluid Dynamics (CFD) at CSIRO - Food and Nutritional Sciences
    Oct 2009 - Apr 2010 · 7 mos

    Pulsed Electric Field Processing (PEF) Microwave Technologies CFD Simulations (COMSOL Multiphysics)