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Laboratory - TECHNICAL LEADER – Bioanalysis - Belgium  

Company managed [?] Still accepting applications
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Posted on : 09 April 2017

Project Description


Description:
Quality Assistance works on innovative medicinal products under development (preclinical and clinical phases). 
The projects are on the development, validation and/or application of analytical methods for the study of small and large molecules in biological matrices by Immunoassays and Bioassays.    Working in a team involved in projects outsourced by our clients, you will:   
  •   Independently develop, validate and apply analytical methods, based on a protocol. 
  •   Process data and write reports and associated supporting documents. 
  •   Manage GLP and GCLP studies and assist the Team Manager in his daily management. 
  •   For the projects assigned to you, you will supervise the personnel involved; do the technical follow-up of analyses (troubleshooting); ensure protocols and contracts are respected, communicate internally and with clients; validate experimental results and ensure protocols are respected; write and/or verify reports; manage documentation related to the analyses done; assist the Team Manager in the preparation of practical work and the writing of protocols (development, qualification, validation and transfer).   


Education  
Master / Engineer (or PhD), specialisation Biology or Biochemistry. 

 
Technical skills  
Thorough theoretical knowledge and practical experience in immunochemistry (Elisa, MSD, Luminex,..) applied to PK, Immunogenicity and Biomarkers studies.  
   

General skills  
  •  Very good knowledge of GLP/GCLP quality norms.         
  • Good knowledge of biological medicinal products (mAbs, ADCs, proteins, recombinant peptides) and regulations associated (EMA and FDA).           
  • Good knowledge of the pharmaceutical sector.     


Language skills  
In addition to proficiency in French, good command of English. 


Experience  
At least 2 years’ practical experience in pharmaceutical sector in development, validation and application of analytical methods in aforementioned techniques. 


Pluses 
  • A first experience as Study Director. 
  • In addition to the fringe benefits received by all the personnel, you will also be provided with a company car.