eDMS Documentum (EMC) implementation QM Modul for SOP Management is implemented and coordinated. Working under a fully CSV and GxP environment under USA and Europen Standards
LIMS from the headquarter is rolled out to international sites. The interfaces to EDMS and different ERP Systems must be implemented coordinated. The Quality unit is the center of this activity and act in a fully CSV and GxP environment.
Employment History
01/2018 ? now BASF SE, Limburgerhof
Project / Activity: Project Coordinator - Data Manager
Project Coordination Digitalisation ? Big Data
Data Management
Master Data
System architecture
Train employee
05/2017 ? 12/2017 Fresenius Kabi, Oberursel
Project / Activity: Project Manager ? Validation Manager
Project Management
Create Validation Documents, PQ, UAT
Work under GxP aspect 21 CFR 11, 210, 211, 820, EMA Annex 11, Eudralex,
Train employee
LIMS from the headquarter is rolled out to international sites. The eDMS Documentum QM Modul must be implemented and coordinated. Working under a fully CSV and GxP environment under USA and Europe Standards with a high focus on new Rules of Data Integrity
08/2016 ? 03/2017 Vifor, Zurich /St. Gallen Switzerland
Project / Activity: Project Manager Business
Act as global project lead and coordinator.
Review Project Plan and propose changes to the steering committee (SC)
Ensure timely execution of all project related action. Escalate resources or budget issues to SC and involved parties (stakeholders, PMs, SC)
Organize and lead project team. Document progress of the project
Ensure that system related issues are identified, tracked and resolved in a timely manner
Trigger and coordinate change control activities as needed
Interact with external vendors as required, ensure that actions are performed and issues resolved within timelines
LIMS from the headquarter is rolled out to international sites. The interfaces to EDMS and different ERP Systems must be implemented coordinated. The Quality unit is the center of this activity and act in a fully CSV and GxP environment.
05/2016 ? 01/2017 Merz, Frankfurt
Project / Activity: Business Analyst
Business Analysis of existing Cheminformatics platform and reorganization existing system in the pharmaceutical department.
Make proactive suggestions of improvements of the in-house drug inventory.
Technologies: Cheminformatics, Drug Discovery, MySQL, Pipeline Pilot, Knime,
01/2016 ? 06/2016 Merck, Darmstadt
Project / Activity: Business Analyst
Feasibility study of existing Data Management
Harmonize different existing platforms to a global LIMS ? DMS and Request Management System
User Requirement Specification
Feature Specification, System Design
Evaluation of a Lab journal
Evaluation of a Request Management System
Technologies: ORACLE, MS SQL Server, MS Access, TANGO, eWorkbook, electronical workflows, Spotfire
03/2015 ? 03/2016 Bayer Healthcare, Berlin
Project / Activity: LIMS Specialist
Evaluation of LIMS and ELN Software from Labware, Biovia, Thermo Fischer, IDBS, Abbott (Starlims)
Implementation of LIMS ?SampleManager? from Thermo Fischer
Validation of LIMS and ELN System
Revision of the existing laboratory structure
Introduction of a paperless lab environment
Empower 2 to 3 Upgrade
CSV Installation of Sample Manager, ELN (Biovia)
Scientific Reporting in BIRT
Technical documentation (URS, FS, IQ, Test Cases, Risk Analysis)
Technologies: ORACLE, Data Integrity, GxP, GAMP, GSOP, Risk Management, Gap Analysis, Technical Documentation, Validation, Sample Manager, ELN Biovia, BIRT, SampleManager Thermo Fischer, ELN Biovia, Data Mapping and Data Migration, JIRA
01/2014 ? 12/2015 BioVersys, Basel
Project / Activity: Data Manager / Cheminformatics Specialist
Analysis of the current laboratory IT structure
Revision of the existing laboratory structure
Automated loading of generated laboratory data into an existing MySQL
database
Technologies: Data Mapping, Data Migration, MySQL, VBA, SQL, INSTANT JCHEM
2013 - 2014 2Basics GmbH, Waldkirchen
Project / Activity: SAP Consultant
Database migrations
Database account management
Individual adaptation of existing database according to customer requirements
Technologies: SAP R3, Oracle, DB2, MSSQL Server, MaxDB, AIX, SOLARIS, Linux
2012 Agennix AG, Martinsried
Project / Activity: Data Analyst / Developer
Analysis of the requirements for a database system for clinical trials
Create a database for recording pre-clinical data
Migration of legacy data
Individual adaptation and further development of the database according to customer requirements with advanced evaluation, search and report functions
Administration and maintenance of the database.
Technologies: MS ACCESS 2007, VBA, ODBC, KNIME.
2011 - 2013 Proteros GmbH, Martinsried
Project / Activity: Data Analyst / Developer
Actual and target analysis of the existing IT platform
Electronic integration of laboratory and IT landscape
Training of employees
Creating and implementing of a new concept for the data management of the entire screening group
Implementation of an electronic lab journal
Negotiations with software manufacturers
Creation and maintenance of biological databases and special tools
Implementation of a self-developed concept for compound logistics of the criteria of Lipinski (3 million chemical substances): Ordering, distribution, quality management
Technologies: SQL, MS SQL SERVER 2008 R2, ORACLE 10, ACTIVITYBASE, VBA, PERL, ISIS BASE, CHEMFINDER, XLFIT, MATHLAB, MOSS, KNIME.
2011 U3 Pharma (Daiichi Sankyo Company, Ltd)
Project / Activity: Data Analyst
Analysis of the existing data structure
Installation of Microsoft Search Server Express of 2010
Installation and Administration of SharePoint Server 2010 as a DMS
Evaluation of different database management systems
Evaluation, installation, administration and development of a reporting system based on Jaspersoft (iReport, JasperServer)
Testing of various electronic lab notebooks from different manufacturers (Accelrys, Quattro). Installation of eLab (Accelry)
Technologies: MS SEARCH SERVER, SHAREPOINT SERVER 2010, LINUX, ORACLE 9, MS SQL SERVER 2010 R2, JASPERSERVER, IREPORT
2008 - 2010 Helmholtz Center Munich
Project / Activity: Team leader / project manager Bioinformatics
Head of Bioinformatics Group (3 FTE)
Introduction, administration and development of a LIMS (Proteus, Genologics), incl. all necessary tests for adequate adaptation of the system
Implementation of LIMS ?Proteus?
Tests for adequate adaptation of the system
All communication with the software manufacturer
Documentation and SOPs for laboratory staff
Introducing a virtual server architecture
Calculations for systems biology
Installation of a wiki
Technologies: PROTEUS, ORACLE, SQL, LINUX, MATHLAB, VMWARE, ESXI, VSPHERE4, JASPERSOFT, WIKI, PIPLINEPILOT, SAMPLE MANAGER von Thermo, DOKUWIKI
2008 Kinaxo Biotechnologies GmbH, Martinsried
Project / Activity: Data manager
Development of calculation tools for scientific data
Technologies: VBA.
2005 - 2008 GPC Biotech AG, Martinsried
Project / Activity: Group leader / Project Manager
Development and management of an automated compound logistics department
Development and establishment of a Quality Management System for a Small Molecule Library according to the criteria of Lipinski
Development of an in-house compound ordering system
Development of programs for liquid handling robot
Integration of technical devices in compound handling (scales, bar-code reader, Liquid pipetting robots, etc.).
Negotiating with software vendors
Development, organization and administration of the compound database
Technologies: SQL, ORACLE, SQLBASE, WINDOWS SERVER, SQL DEVELOPER, CONFLUENCE, Activity Base, VBA, Access, Datenmigration
2001 - 2005 Axxima Pharmaceuticals AG, Martinsried
Project / Activity: Scientist II / Group Leader / Project Manager
Structure of the automation department for the compound coordination
Adaptation of the technical devices for reading the raw data
Implementation and administration of Activity Base (IDBS)
Construction of different databases for the chemistry and biology
Cloning and genomic assays in the department
Evaluation and visualization of genomic data
Staff training in biological and chemical software
Technologies: ORACLE , ACTIVITYBASE (IDBS), SQL, FILEMAKER, ODBS, C+, .NET, VISUAL STUDIO.
2002 Academia Ruprecht-Karls-University Heidelberg
Education: Bioinformatics
Certificate of the Postgraduate Program Bioinformatics
Technologies: LIMS systems (LabView), electronic Labor journals (ChambgridgeSoft), C+, Perl, VB(A), databases, Sequence analysis, Statistics, calculating biochemical cycle
03/1999 ? 03/2000 Roche Bioscience, Palo Alto, USA
Fachhochschule, Jülich, Germany
Education: Dipl.-Ing, Fellowship and Diploma Theses
Chad D. Paavola, Stefan Hemmerich, Dorit Grunberger, Irene Polsky, Adam Bloom, Richard Freedman, Mary Mulkins, Sunhil Bhakta, Debbie McCarley, Ludwig Wiesent, Belinda Wong, Kurt Jarnagin, and Tracy M. Handel
Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B
J. Biol. Chem., Dec 1998; 273: 33157 ? 33165.
Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B
2002: Bioinformatics
Academia Ruprecht-Karls-University Heidelberg
Certificate of the Postgraduate Program Bioinformatics
Technologies:
LIMS systems (LabView), electronic Labor journals (ChambgridgeSoft), C+, Perl, VB(A), databases, Sequence analysis, Statistics, calculating biochemical cycle
Data Management and Project management for IT infrastructure in the area PHARMACY / CHEMISTRY / LIFE SCIENCE
Portfolio
Knowledge and methods
Thesis and paper:
Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B (@ Roche Bioscience, Palo Alto, USA)
Biotech, Pharma, Life Science
eDMS Documentum (EMC) implementation QM Modul for SOP Management is implemented and coordinated. Working under a fully CSV and GxP environment under USA and Europen Standards
LIMS from the headquarter is rolled out to international sites. The interfaces to EDMS and different ERP Systems must be implemented coordinated. The Quality unit is the center of this activity and act in a fully CSV and GxP environment.
Employment History
01/2018 ? now BASF SE, Limburgerhof
Project / Activity: Project Coordinator - Data Manager
Project Coordination Digitalisation ? Big Data
Data Management
Master Data
System architecture
Train employee
05/2017 ? 12/2017 Fresenius Kabi, Oberursel
Project / Activity: Project Manager ? Validation Manager
Project Management
Create Validation Documents, PQ, UAT
Work under GxP aspect 21 CFR 11, 210, 211, 820, EMA Annex 11, Eudralex,
Train employee
LIMS from the headquarter is rolled out to international sites. The eDMS Documentum QM Modul must be implemented and coordinated. Working under a fully CSV and GxP environment under USA and Europe Standards with a high focus on new Rules of Data Integrity
08/2016 ? 03/2017 Vifor, Zurich /St. Gallen Switzerland
Project / Activity: Project Manager Business
Act as global project lead and coordinator.
Review Project Plan and propose changes to the steering committee (SC)
Ensure timely execution of all project related action. Escalate resources or budget issues to SC and involved parties (stakeholders, PMs, SC)
Organize and lead project team. Document progress of the project
Ensure that system related issues are identified, tracked and resolved in a timely manner
Trigger and coordinate change control activities as needed
Interact with external vendors as required, ensure that actions are performed and issues resolved within timelines
LIMS from the headquarter is rolled out to international sites. The interfaces to EDMS and different ERP Systems must be implemented coordinated. The Quality unit is the center of this activity and act in a fully CSV and GxP environment.
05/2016 ? 01/2017 Merz, Frankfurt
Project / Activity: Business Analyst
Business Analysis of existing Cheminformatics platform and reorganization existing system in the pharmaceutical department.
Make proactive suggestions of improvements of the in-house drug inventory.
Technologies: Cheminformatics, Drug Discovery, MySQL, Pipeline Pilot, Knime,
01/2016 ? 06/2016 Merck, Darmstadt
Project / Activity: Business Analyst
Feasibility study of existing Data Management
Harmonize different existing platforms to a global LIMS ? DMS and Request Management System
User Requirement Specification
Feature Specification, System Design
Evaluation of a Lab journal
Evaluation of a Request Management System
Technologies: ORACLE, MS SQL Server, MS Access, TANGO, eWorkbook, electronical workflows, Spotfire
03/2015 ? 03/2016 Bayer Healthcare, Berlin
Project / Activity: LIMS Specialist
Evaluation of LIMS and ELN Software from Labware, Biovia, Thermo Fischer, IDBS, Abbott (Starlims)
Implementation of LIMS ?SampleManager? from Thermo Fischer
Validation of LIMS and ELN System
Revision of the existing laboratory structure
Introduction of a paperless lab environment
Empower 2 to 3 Upgrade
CSV Installation of Sample Manager, ELN (Biovia)
Scientific Reporting in BIRT
Technical documentation (URS, FS, IQ, Test Cases, Risk Analysis)
Technologies: ORACLE, Data Integrity, GxP, GAMP, GSOP, Risk Management, Gap Analysis, Technical Documentation, Validation, Sample Manager, ELN Biovia, BIRT, SampleManager Thermo Fischer, ELN Biovia, Data Mapping and Data Migration, JIRA
01/2014 ? 12/2015 BioVersys, Basel
Project / Activity: Data Manager / Cheminformatics Specialist
Analysis of the current laboratory IT structure
Revision of the existing laboratory structure
Automated loading of generated laboratory data into an existing MySQL
database
Technologies: Data Mapping, Data Migration, MySQL, VBA, SQL, INSTANT JCHEM
2013 - 2014 2Basics GmbH, Waldkirchen
Project / Activity: SAP Consultant
Database migrations
Database account management
Individual adaptation of existing database according to customer requirements
Technologies: SAP R3, Oracle, DB2, MSSQL Server, MaxDB, AIX, SOLARIS, Linux
2012 Agennix AG, Martinsried
Project / Activity: Data Analyst / Developer
Analysis of the requirements for a database system for clinical trials
Create a database for recording pre-clinical data
Migration of legacy data
Individual adaptation and further development of the database according to customer requirements with advanced evaluation, search and report functions
Administration and maintenance of the database.
Technologies: MS ACCESS 2007, VBA, ODBC, KNIME.
2011 - 2013 Proteros GmbH, Martinsried
Project / Activity: Data Analyst / Developer
Actual and target analysis of the existing IT platform
Electronic integration of laboratory and IT landscape
Training of employees
Creating and implementing of a new concept for the data management of the entire screening group
Implementation of an electronic lab journal
Negotiations with software manufacturers
Creation and maintenance of biological databases and special tools
Implementation of a self-developed concept for compound logistics of the criteria of Lipinski (3 million chemical substances): Ordering, distribution, quality management
Technologies: SQL, MS SQL SERVER 2008 R2, ORACLE 10, ACTIVITYBASE, VBA, PERL, ISIS BASE, CHEMFINDER, XLFIT, MATHLAB, MOSS, KNIME.
2011 U3 Pharma (Daiichi Sankyo Company, Ltd)
Project / Activity: Data Analyst
Analysis of the existing data structure
Installation of Microsoft Search Server Express of 2010
Installation and Administration of SharePoint Server 2010 as a DMS
Evaluation of different database management systems
Evaluation, installation, administration and development of a reporting system based on Jaspersoft (iReport, JasperServer)
Testing of various electronic lab notebooks from different manufacturers (Accelrys, Quattro). Installation of eLab (Accelry)
Technologies: MS SEARCH SERVER, SHAREPOINT SERVER 2010, LINUX, ORACLE 9, MS SQL SERVER 2010 R2, JASPERSERVER, IREPORT
2008 - 2010 Helmholtz Center Munich
Project / Activity: Team leader / project manager Bioinformatics
Head of Bioinformatics Group (3 FTE)
Introduction, administration and development of a LIMS (Proteus, Genologics), incl. all necessary tests for adequate adaptation of the system
Implementation of LIMS ?Proteus?
Tests for adequate adaptation of the system
All communication with the software manufacturer
Documentation and SOPs for laboratory staff
Introducing a virtual server architecture
Calculations for systems biology
Installation of a wiki
Technologies: PROTEUS, ORACLE, SQL, LINUX, MATHLAB, VMWARE, ESXI, VSPHERE4, JASPERSOFT, WIKI, PIPLINEPILOT, SAMPLE MANAGER von Thermo, DOKUWIKI
2008 Kinaxo Biotechnologies GmbH, Martinsried
Project / Activity: Data manager
Development of calculation tools for scientific data
Technologies: VBA.
2005 - 2008 GPC Biotech AG, Martinsried
Project / Activity: Group leader / Project Manager
Development and management of an automated compound logistics department
Development and establishment of a Quality Management System for a Small Molecule Library according to the criteria of Lipinski
Development of an in-house compound ordering system
Development of programs for liquid handling robot
Integration of technical devices in compound handling (scales, bar-code reader, Liquid pipetting robots, etc.).
Negotiating with software vendors
Development, organization and administration of the compound database
Technologies: SQL, ORACLE, SQLBASE, WINDOWS SERVER, SQL DEVELOPER, CONFLUENCE, Activity Base, VBA, Access, Datenmigration
2001 - 2005 Axxima Pharmaceuticals AG, Martinsried
Project / Activity: Scientist II / Group Leader / Project Manager
Structure of the automation department for the compound coordination
Adaptation of the technical devices for reading the raw data
Implementation and administration of Activity Base (IDBS)
Construction of different databases for the chemistry and biology
Cloning and genomic assays in the department
Evaluation and visualization of genomic data
Staff training in biological and chemical software
Technologies: ORACLE , ACTIVITYBASE (IDBS), SQL, FILEMAKER, ODBS, C+, .NET, VISUAL STUDIO.
2002 Academia Ruprecht-Karls-University Heidelberg
Education: Bioinformatics
Certificate of the Postgraduate Program Bioinformatics
Technologies: LIMS systems (LabView), electronic Labor journals (ChambgridgeSoft), C+, Perl, VB(A), databases, Sequence analysis, Statistics, calculating biochemical cycle
03/1999 ? 03/2000 Roche Bioscience, Palo Alto, USA
Fachhochschule, Jülich, Germany
Education: Dipl.-Ing, Fellowship and Diploma Theses
Chad D. Paavola, Stefan Hemmerich, Dorit Grunberger, Irene Polsky, Adam Bloom, Richard Freedman, Mary Mulkins, Sunhil Bhakta, Debbie McCarley, Ludwig Wiesent, Belinda Wong, Kurt Jarnagin, and Tracy M. Handel
Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B
J. Biol. Chem., Dec 1998; 273: 33157 ? 33165.
Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B
2002: Bioinformatics
Academia Ruprecht-Karls-University Heidelberg
Certificate of the Postgraduate Program Bioinformatics
Technologies:
LIMS systems (LabView), electronic Labor journals (ChambgridgeSoft), C+, Perl, VB(A), databases, Sequence analysis, Statistics, calculating biochemical cycle
Data Management and Project management for IT infrastructure in the area PHARMACY / CHEMISTRY / LIFE SCIENCE
Portfolio
Knowledge and methods
Thesis and paper:
Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B (@ Roche Bioscience, Palo Alto, USA)
Biotech, Pharma, Life Science