Project coordinator / process validation for viral vector production

Novasep

New Product Introduction - Project Manager: transfer of production processes from customers to CMO production facility 

Catalent

Project Manager in Cell & Gene Therapy

Development and Manufacturing

MastherCell

Qualification and Validation Engineer 

UCB

New Product Introduction - Project Manager

Catalent

Senior Project Engineer:

- project coordination for extension of production facility

- Equipment Qualification/Process Validation for new production facility

Biocartis (Medical Devices)

New Product Introduction - Project Manager

Catalent

Process Engineer for new biopilot facility (cellular culture) : process setup and troubleshooting for automatic cleaning equipment (CIP, washers) - UCB

Cleaning Validation Associate for new biopilot facility (cellular culture) - UCB

QA coach for QA oversight in qualification/validation

QA systems - Validation - GSK Vaccines

Qualification and Validation Specialist - Redectane® project EU

Coordination of Redectane® project – New Jersey, US - IBA Molecular

Coordination of validation projects - GSK Vaccines

Validation of a automated dispensing system - IBA Molecular

Definition of the site strategy for production equipments cleaning validation - Labima

Set up of general strategies and procedures for deviations and CAPA management - Labima

Coordinate Process transfer validation from customer to Catalent (injectable drugs and vaccines filled insyringes) - Catalent

Supervision of a production department (35 persons):weighing, mixing and cleaning operations - Baxter SA

Coordination of the process transfer to Lessines and writing of production procedures  - Baxter SA

Project management for Validation of QC equipments - IRE

Assistance in performing an FDA pre-inspection of a contract manufacturer site - ThrombX

Coordination of the process transfer to Lessines and writing of production procedures  - Baxter SA

Management and execution of stability and compatibility studies of drugs in the Baxter devices - Baxter R&D Europe

Preparation of process transfer from R&D to industrialization - GSK Vaccines