Volker Brenner

CSV Expert at Takeda

Constance, Baden-Württemberg, Germany

About

Computer System Validation expert that combines extensive bioinformatics and molecular biology expertise with excellent communication skills. Equally experienced in project- and line-management. Enjoys working with multi-disciplinary teams and to facilitate close interaction between different disciplines such as molecular biology and IT. Skills: CSV Expert, Validation Plan, Risk Assessment, URS, OQ, PQ, GxP, Lab Instrument Qualification, Project Management, Audit, Annex 11, GAMP 5, 21 CFR Part 11, Data Integrity, ALCOA+, Quality Risk Management, Change Management Qualifications: Certified Chromeleon administrator Certified LabWare LIMS administrator Trained MODA administrator ECA Certified Computer Validation Manager ECA Certified Data Integrity Manager

Experience

  • Takeda (8 yrs 3 mos)
    • CSV Specialist
      Apr 2018 - Present · 8 yrs 3 mos

    • Digitalization Engineer Quality Assurance
      Apr 2018 - Present · 8 yrs 3 mos

  • GATC Biotech (Konstanz Area, Germany)
    • Head of Inside Sales and Customer Care
      Jan 2016 - Mar 2018 · 2 yrs 3 mos

    • Head of Bioinformatics
      May 2012 - Dec 2015 · 3 yrs 8 mos

      - Manage Illumina HiSeq 2500 and 4000, MiSeq, PacBio RS II and Roche GS FLX NGS projects - Provide data analysis for genome re-sequencing, targeted re-sequencing, de-novo sequencing, RNA-Seq and special applications

  • OGT (8 yrs 1 mo)
    • Head of Computational Biology
      Oct 2008 - Mar 2012 · 3 yrs 6 mos

      - Product development for cytogenetics, molecular genetics and cancer diagnostics - Guiding development of commercial software applications - Statistical data analysis of microarray data and NGS data - Project management of internal, external and collaborative studies - Biomarker Discovery

    • Senior Computational Biologist
      Mar 2004 - Oct 2008 · 4 yrs 8 mos

      Development of several OGT products including the CytoSure SyndromePlus microarray for cytogenetics and the CytoSure DMD array for molecular genetics. Conception and implementation of the OligomeTM, a resource enabling OGT to offer bespoke gene expression, methylation and aCGH microarray designs.

  • Senior Scientist at Inpharmatica
    May 2000 - Jan 2004 · 3 yrs 9 mos

    Project analysis, project management and a substantial part of the actual scientific and technical implementation of several core components of the PharmaCartaTM Chemogenomics platform. ORACLE database design and GUI implementation of DrugStore and StARlite. These databases link chemical, biological and medicinal data and are now being hosted by ChEMBL at the EBI.

  • Research Scientist at Aventis
    1998 - 2000 · 2 yrs

    Development of numerous tools for sequence annotation and microarray data analysis for target discovery. Key contributions to a patent application. In my function as line manager of 3 bioinformaticians I had to co-ordinate our efforts with the global bioinformatics core group in Hayward, USA.