Laborautomation, LIMS, ELN, GxP, CSV, Validation, Pharma, Labor Logistik, Data management, Cheminformatics, Projekt Mangagement, Master Data
Aktualisiert am 29.04.2024
Profil
Freiberufler / Selbstständiger
Verfügbar ab: 01.05.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Quality Management
Data management
Data Integrity
Master Data
EQMS
LIMS
Paperless lab
ELN
CSV
English
fluent 
German
mother tongue
Spanish
basic

Einsatzorte

Einsatzorte

Deutschland
nicht möglich

Projekte

Projekte

1 Jahr
2018-01 - 2018-12

Project Coordinator

Data Manager ELN masterdatamanagement Catalog Management ...
Data Manager
  • Acquisition of Requirements
  • Improvement of current ELN
  • Masterdata and Catalog
  • Evaluation of cheminformatic tools
eWorkbook ActivityBase Browser (Dotmatics) Bioregister Vortex Talend StudyELN
ELN masterdatamanagement Catalog Management Data management
BASF SE
Limburgerhof
8 Monate
2017-05 - 2017-12

Project Coordinator - Validation Document Writer

Project Manager ? Validation Manager Computerized System Validation
Project Manager ? Validation Manager
  • Project Management
  • Create Validation Documents, PQ, UAT
  • Perform workshops for employee

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

EMC Documentum JIRA
Computerized System Validation
Fresenius Kabi, Oberursel
8 Monate
2016-08 - 2017-03

Projekt Management

Project Lead Annex 11 CSV Project Methology ...
Project Lead
  • 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.

Annex 11 CSV Project Methology LABSQ von iCD
Vifor Pharma
St. Gallen
9 Monate
2016-05 - 2017-01

Business Analysis of existing Cheminformatics platform and reorganization existing system in the pharmaceutical department

Business Analyst Cheminformatics Compound Logistic Drug Discovery ...
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 
Cheminformatics Compound Logistic Drug Discovery MYSQL KNIME Pipeline Pilot
Merz Pharma
Frankfurt
6 Monate
2016-01 - 2016-06

Feasibility study of existing Data Management

LIMS Specialist Oracle MS SQL Server MS Access ...
LIMS Specialist
  • 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
Oracle MS SQL Server MS Access TANGO eWorkbook TIBCO Spotfire
Merck
Darmstadt
1 Jahr 1 Monat
2015-03 - 2016-03

Implementation of LIMS ?SampleManager?

LIMS Specialist ORACLE GxP GAMP ...
LIMS Specialist
  • Implementation of LIMS „SampleManager“
  • Validation of LIMS and ELN System
  • Revision of the existing laboratory structure
  • Introduction of a paperless lab environment
  • CSV Installation of Sample Manager, ELN und RequestManager (Biovia)
  • Scientific Reporting in BIRT
  • Technical documentation (URS, FS, IQ, Test Cases, Risk Analysis)
Labware
ORACLE GxP GAMP GSOP Risk Management Technical Documentation Validation Sample Manager ELN Biovia BIRT SampleManager Thermo Fischer ELN Biovia
Bayer Business Services
Berlin
2 Jahre
2014-01 - 2015-12

Analysis of the current laboratory IT structure

Chemical Data Manager MySQL VBA SQL ...
Chemical Data Manager
  • Analysis of the current laboratory IT structure
  • Revision of the existing laboratory structure
  • Automated loading of generated laboratory data into an existing MySQL database
MySQL VBA SQL INSTANT JCHEM
BioVersys
Basel
1 Jahr 11 Monate
2013-01 - 2014-11

Database migrations

SAP Basis Consultant SAP R3 DB2 Oracle ...
SAP Basis Consultant
  • Database migrations
  • Database account management
  • Individual adaptation of existing database according to customer requirements
SAP R3 DB2 Oracle Microsoft SQL Server SAP MaxDB AIX Admin Solaris Administration von Linuxservern
2Basics
Waldkirchen
2 Jahre 4 Monate
2011-02 - 2013-05

Actual and target analysis of the existing IT platform

Data Manager SQL MS SQL SERVER 2008 R2 ORACLE 10 ...
Data Manager
  • 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
SQL MS SQL SERVER 2008 R2 ORACLE 10 ACTIVITYBASE VBA PERL ISIS BASE CHEMFINDER XLFIT MATHLAB MOSS KNIME
Proteros GmbH
Martinsried
2 Jahre 10 Monate
2008-04 - 2011-01

Head of Bioinformatics

Group Leader PROTEUS ORACLE SQL ...
Group Leader
  • Head of Bioinformatics Group (5 FTE)
  • Introduction, administration and development of a LIMS (Proteus, Genologics), incl. all necessary tests for adequate adaptation of the system
  • Tests for adequate adaptation of the system
  • Communication with the software manufacturer
  • Documentation and SOPs
  • Introducing a virtual server architecture
  • Calculations for systems biology
  • Introduction of a knowledge wiki
PROTEUS ORACLE SQL LINUX MATHLAB VMWARE ESXI VSPHERE4 JASPERSOFT WIKI PIPLINEPILOT SAMPLE MANAGER von Thermo DOKUWIKI
Helmholz Zentrum
München

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Jahr 1 Monat
1999-03 - 2000-03

Dipl.-Ing. Fellowship and Diploma Theses

Dipl.-Ing, Roche Bioscience, Palo Alto, USA und Fachhochschule, Jülich, Germany
Dipl.-Ing
Roche Bioscience, Palo Alto, USA und Fachhochschule, Jülich, Germany

Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B

Kompetenzen

Kompetenzen

Top-Skills

Quality Management Data management Data Integrity Master Data EQMS LIMS Paperless lab ELN CSV

Schwerpunkte

CSV
Computer System Validation
Data management
Drug Discovery
GAMP
GxP

Data Management and Project management for IT infrastructure in the area PHARMACY / CHEMISTRY / LIFE SCIENCE

  • Project Lead, Tech Project Management, Project Coordinator, Head Medical compound logistics, Chem-Informatics, lab logistic solutions, system architecture, embedded lab equipment (HPLC, MS, ?), business analysis, drug discovery, LIMS, ELN, eDMS, data visualization, Electronic Laboratory Notebook, GxP, Scientific Reporting, CSV, Quality, Validation, Masterdata Management

Aufgabenbereiche

Computerized System Validation
ELN
masterdatamanagement
Risk Management
Technical Documentation
Validation

Produkte / Standards / Erfahrungen / Methoden

ActivityBase
Bioregister
Biovia
BIRT
BIRT ELN
Browser (Dotmatics)
Catalog Management
CMS
Compound Logistic Konzepte
Compound QS
DMS
Dotmatics
ECM
ELN
EMC Documentum
eWorkbook
JIRA
Labware
LIMS
oracle
Pipeline Pilot
Proteus
Sample Manager
SampleManager
SampleManager Thermo Fischer
StudyELN
Talend
Themo Fischer
vmware
Vortex

Portfolio

  • Project Management, Project Coordination in validated environment in Pharma
  • Writing CVS documents
  • Very good knowledge of the technical equipment in a pharmaceutical lab (HPLC, MS, ?)
  • High level of expertise in automation and electronic control of laboratory processes in the pharmaceutical research area
  • Many years of experience in networking equipment and IT systems (LIMS, ELN, eDMS)
  • Very experienced coordinator between the interface of biology, chemistry and IT
  • High social competence leading relevant parties to an automated IT structure
  • Experience in validation of computerized systems (CSV)
  • Competence in improvement of system architecture (GxP)
  • Optimization of lab logistic solutions
  • Creative engineer with view of project processes and technical understanding

 

Knowledge and methods

  • GxP and CSV experience
  • Quality, GAMP 5, EMEA Annex 11, FDA 21CFR part11
  • SAP ERP experience
  • Many years of experience in dealing with different operating systems and databases in Chemistry
  • Competence in Integration of laboratory equipment with IT infrastructure
  • Development and management of a chemical compound logistics automation department (5 employees)
  • Coordination of complex work-flows for the cooperation of IT, technical devices and databases
  • High level of expertise in the management of different data from different devices and applications (HPLC, MS, HPLC-MS-MS, Thermo Orbitrap, Bar-code Reader, label printer, UV reader, alarm function, liquid handling robot
  • Versed in ECM, CMS and DMS
  • Evaluating and setting up reporting servers (JasperSoft, BIRT) and visualize data
  • Developing and establishing quality management for a chemical compound library
  • Knowledge of scripting and programming languages such as Perl, SQL, VB, .NET, C +
  • Many years of experience in the creation and administration of databases
  • Introduction of electronic laboratory journals
  • Routine in dealing with virtual environments

Betriebssysteme

Linux
Mac
Windows

Programmiersprachen

KNIME
Pearl
Phyton
SQL
VB
VBA

Datenbanken

Cheminformatics
Filemaker
LABSQ von iCD
MYSQL
postgres
Qracle

Datenkommunikation

GSOP
Request Management System

Berechnung / Simulation / Versuch / Validierung

Annex 11
Cluster Analsysis
CSV
mathlab
r
xlfit

Design / Entwicklung / Konstruktion

Compound Logistic

Managementerfahrung in Unternehmen

Project Methology

Branchen

Branchen

Biotech, Pharma, Life Science

Einsatzorte

Einsatzorte

Deutschland
nicht möglich

Projekte

Projekte

1 Jahr
2018-01 - 2018-12

Project Coordinator

Data Manager ELN masterdatamanagement Catalog Management ...
Data Manager
  • Acquisition of Requirements
  • Improvement of current ELN
  • Masterdata and Catalog
  • Evaluation of cheminformatic tools
eWorkbook ActivityBase Browser (Dotmatics) Bioregister Vortex Talend StudyELN
ELN masterdatamanagement Catalog Management Data management
BASF SE
Limburgerhof
8 Monate
2017-05 - 2017-12

Project Coordinator - Validation Document Writer

Project Manager ? Validation Manager Computerized System Validation
Project Manager ? Validation Manager
  • Project Management
  • Create Validation Documents, PQ, UAT
  • Perform workshops for employee

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

EMC Documentum JIRA
Computerized System Validation
Fresenius Kabi, Oberursel
8 Monate
2016-08 - 2017-03

Projekt Management

Project Lead Annex 11 CSV Project Methology ...
Project Lead
  • 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.

Annex 11 CSV Project Methology LABSQ von iCD
Vifor Pharma
St. Gallen
9 Monate
2016-05 - 2017-01

Business Analysis of existing Cheminformatics platform and reorganization existing system in the pharmaceutical department

Business Analyst Cheminformatics Compound Logistic Drug Discovery ...
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 
Cheminformatics Compound Logistic Drug Discovery MYSQL KNIME Pipeline Pilot
Merz Pharma
Frankfurt
6 Monate
2016-01 - 2016-06

Feasibility study of existing Data Management

LIMS Specialist Oracle MS SQL Server MS Access ...
LIMS Specialist
  • 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
Oracle MS SQL Server MS Access TANGO eWorkbook TIBCO Spotfire
Merck
Darmstadt
1 Jahr 1 Monat
2015-03 - 2016-03

Implementation of LIMS ?SampleManager?

LIMS Specialist ORACLE GxP GAMP ...
LIMS Specialist
  • Implementation of LIMS „SampleManager“
  • Validation of LIMS and ELN System
  • Revision of the existing laboratory structure
  • Introduction of a paperless lab environment
  • CSV Installation of Sample Manager, ELN und RequestManager (Biovia)
  • Scientific Reporting in BIRT
  • Technical documentation (URS, FS, IQ, Test Cases, Risk Analysis)
Labware
ORACLE GxP GAMP GSOP Risk Management Technical Documentation Validation Sample Manager ELN Biovia BIRT SampleManager Thermo Fischer ELN Biovia
Bayer Business Services
Berlin
2 Jahre
2014-01 - 2015-12

Analysis of the current laboratory IT structure

Chemical Data Manager MySQL VBA SQL ...
Chemical Data Manager
  • Analysis of the current laboratory IT structure
  • Revision of the existing laboratory structure
  • Automated loading of generated laboratory data into an existing MySQL database
MySQL VBA SQL INSTANT JCHEM
BioVersys
Basel
1 Jahr 11 Monate
2013-01 - 2014-11

Database migrations

SAP Basis Consultant SAP R3 DB2 Oracle ...
SAP Basis Consultant
  • Database migrations
  • Database account management
  • Individual adaptation of existing database according to customer requirements
SAP R3 DB2 Oracle Microsoft SQL Server SAP MaxDB AIX Admin Solaris Administration von Linuxservern
2Basics
Waldkirchen
2 Jahre 4 Monate
2011-02 - 2013-05

Actual and target analysis of the existing IT platform

Data Manager SQL MS SQL SERVER 2008 R2 ORACLE 10 ...
Data Manager
  • 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
SQL MS SQL SERVER 2008 R2 ORACLE 10 ACTIVITYBASE VBA PERL ISIS BASE CHEMFINDER XLFIT MATHLAB MOSS KNIME
Proteros GmbH
Martinsried
2 Jahre 10 Monate
2008-04 - 2011-01

Head of Bioinformatics

Group Leader PROTEUS ORACLE SQL ...
Group Leader
  • Head of Bioinformatics Group (5 FTE)
  • Introduction, administration and development of a LIMS (Proteus, Genologics), incl. all necessary tests for adequate adaptation of the system
  • Tests for adequate adaptation of the system
  • Communication with the software manufacturer
  • Documentation and SOPs
  • Introducing a virtual server architecture
  • Calculations for systems biology
  • Introduction of a knowledge wiki
PROTEUS ORACLE SQL LINUX MATHLAB VMWARE ESXI VSPHERE4 JASPERSOFT WIKI PIPLINEPILOT SAMPLE MANAGER von Thermo DOKUWIKI
Helmholz Zentrum
München

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Jahr 1 Monat
1999-03 - 2000-03

Dipl.-Ing. Fellowship and Diploma Theses

Dipl.-Ing, Roche Bioscience, Palo Alto, USA und Fachhochschule, Jülich, Germany
Dipl.-Ing
Roche Bioscience, Palo Alto, USA und Fachhochschule, Jülich, Germany

Monomeric Monocyte Chemoattractant Protein-1 (MCP-1) Binds and Activates the MCP-1 Receptor CCR2B

Kompetenzen

Kompetenzen

Top-Skills

Quality Management Data management Data Integrity Master Data EQMS LIMS Paperless lab ELN CSV

Schwerpunkte

CSV
Computer System Validation
Data management
Drug Discovery
GAMP
GxP

Data Management and Project management for IT infrastructure in the area PHARMACY / CHEMISTRY / LIFE SCIENCE

  • Project Lead, Tech Project Management, Project Coordinator, Head Medical compound logistics, Chem-Informatics, lab logistic solutions, system architecture, embedded lab equipment (HPLC, MS, ?), business analysis, drug discovery, LIMS, ELN, eDMS, data visualization, Electronic Laboratory Notebook, GxP, Scientific Reporting, CSV, Quality, Validation, Masterdata Management

Aufgabenbereiche

Computerized System Validation
ELN
masterdatamanagement
Risk Management
Technical Documentation
Validation

Produkte / Standards / Erfahrungen / Methoden

ActivityBase
Bioregister
Biovia
BIRT
BIRT ELN
Browser (Dotmatics)
Catalog Management
CMS
Compound Logistic Konzepte
Compound QS
DMS
Dotmatics
ECM
ELN
EMC Documentum
eWorkbook
JIRA
Labware
LIMS
oracle
Pipeline Pilot
Proteus
Sample Manager
SampleManager
SampleManager Thermo Fischer
StudyELN
Talend
Themo Fischer
vmware
Vortex

Portfolio

  • Project Management, Project Coordination in validated environment in Pharma
  • Writing CVS documents
  • Very good knowledge of the technical equipment in a pharmaceutical lab (HPLC, MS, ?)
  • High level of expertise in automation and electronic control of laboratory processes in the pharmaceutical research area
  • Many years of experience in networking equipment and IT systems (LIMS, ELN, eDMS)
  • Very experienced coordinator between the interface of biology, chemistry and IT
  • High social competence leading relevant parties to an automated IT structure
  • Experience in validation of computerized systems (CSV)
  • Competence in improvement of system architecture (GxP)
  • Optimization of lab logistic solutions
  • Creative engineer with view of project processes and technical understanding

 

Knowledge and methods

  • GxP and CSV experience
  • Quality, GAMP 5, EMEA Annex 11, FDA 21CFR part11
  • SAP ERP experience
  • Many years of experience in dealing with different operating systems and databases in Chemistry
  • Competence in Integration of laboratory equipment with IT infrastructure
  • Development and management of a chemical compound logistics automation department (5 employees)
  • Coordination of complex work-flows for the cooperation of IT, technical devices and databases
  • High level of expertise in the management of different data from different devices and applications (HPLC, MS, HPLC-MS-MS, Thermo Orbitrap, Bar-code Reader, label printer, UV reader, alarm function, liquid handling robot
  • Versed in ECM, CMS and DMS
  • Evaluating and setting up reporting servers (JasperSoft, BIRT) and visualize data
  • Developing and establishing quality management for a chemical compound library
  • Knowledge of scripting and programming languages such as Perl, SQL, VB, .NET, C +
  • Many years of experience in the creation and administration of databases
  • Introduction of electronic laboratory journals
  • Routine in dealing with virtual environments

Betriebssysteme

Linux
Mac
Windows

Programmiersprachen

KNIME
Pearl
Phyton
SQL
VB
VBA

Datenbanken

Cheminformatics
Filemaker
LABSQ von iCD
MYSQL
postgres
Qracle

Datenkommunikation

GSOP
Request Management System

Berechnung / Simulation / Versuch / Validierung

Annex 11
Cluster Analsysis
CSV
mathlab
r
xlfit

Design / Entwicklung / Konstruktion

Compound Logistic

Managementerfahrung in Unternehmen

Project Methology

Branchen

Branchen

Biotech, Pharma, Life Science

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