Dr. Rafal Maksym

Bis 2022, Quality Systems & Validation - Change Control, Roche Diagnostics GmbH Deutschland, Penzberg
Abschluss: PhD in Biochemistry, Ludwig-Maximilians-Universität München
Munich, Germany

Fähigkeiten und Kenntnisse

Research
Biochemistry
Biotechnology
Molecular biology
Plant Sciences
Quality Management
Project management
Regulatory Affairs
Microbiology
Life sciences
Cell Biology
Biology

Werdegang

Berufserfahrung von Rafal Maksym

  • Current 4 years and 3 months, since Mar 2022

    Validation Manager

    Boehringer Ingelheim, Biberach

  • 2 years and 2 months, 2020 - Feb 2022

    Quality Systems & Validation - Change Control

    Kelly Services
  • 2 years and 2 months, 2020 - Feb 2022

    Quality Systems & Validation - Change Control

    Roche Diagnostics GmbH Deutschland, Penzberg

  • 2018 - 2020

    Validation Specialist / Consultant

    PQE Deutschland GmbH

    - Prospective and retrospective validation of computerized systems - Assessment of compliance to GxP (CFR21 Part11, EU cGMP Annex 11) - GxP Risk Assessment - Electronic Records re-qualification - Data migration - Preparation of SOPs - Main customers: CSL Behring, Mylan, Roche

  • 2016 - 2017

    Life Science Management Seminar

    ATV Ausbildung Training Vernetzung GmbH

    Professional Training in Life Science Management. Main subjects: - Pharma-Management: Quality Management, Regulatory Affairs, Clinical Studies - Project Management - Team Leadership, Self Management

  • 2011 - 2016

    Research Scientist ( Doctoral Candidate)

    Helmholtz Zentrum München

    - PhD in Biochemistry - Planning and execution of research projects related to analytics, metabolomics and regulation of gene expression - Dissertation: "Arabidopsis small molecule glucosyltransferase UGT76B1 conjugates both ILA and SA and is essential for the root-driven control of defense marker genes in leaves"

  • 1 year and 9 months, Jan 2010 - Sep 2011

    Research assistant

    Institute of Bioorganic Chemistry Polish Academy of Sciences (IBCH PAS)

    - Project: “Elaboration of an innovative technology for RNA synthesis and RNA microarrays construction” - Design, preparation and validation of microarrays

  • 1 year and 3 months, Oct 2008 - Dec 2009

    Research Assistant (Master Thesis Project)

    Institute of Bioorganic Chemistry Polish Academy of Sciences (IBCH PAS)

    - Master thesis on “Changes inducted by abiotic stress in Nicotiana tabacum transcriptome – studies involving cross species hybridization” - Participation in a new method development to monitor transcritptional changes in tobacco by the use of tomato microarray

  • 2 months, Jul 2008 - Aug 2008

    Internship

    University of Natural Resources and Life Sciences (BOKU) Vienna

    Support by microbial inhibition tests and microbes identification.

  • 10 months, Apr 2007 - Jan 2008

    Internship

    Center of Excellence for Nucleic Acid-based Technologies,IBCH PAS

    General support in biochemistry laboratory.

Ausbildung von Rafal Maksym

  • 2011 - 2016

    Biochemistry

    Ludwig-Maximilians-Universität München

  • 6 months, Feb 2008 - Jul 2008

    Biotechnology

    University of Natural Resources and Life Sciences, Vienna (BOKU)

    Socrates/Erasmus Scholarship

  • 5 years and 3 months, Oct 2004 - Dec 2009

    Biotechnology

    Poznań University of Life Sciences, Poland

Sprachen

  • Polish

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • German

    C1 (Fließend)

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