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Skilled NBE and / or Biomarker Regulatory Bioanalytical Scientist - Belgium  

Company managed [?] Still accepting applications

Posted on : 09 December 2016

Project Description

Nature and scope: 
The scope of the role is focused on supporting regulatory bioanalysis across our biologics portfolio. This role is heavily lab based. 

Major accountabilities:   
  • Lab based role focused on development, validation and application of bioanalytical methods either for PK, ADA or Biomarker analysis 
  • Work closely with the project bioanalytical representatives to ensure  effective  knowledge transfer of bioanalytical methods to CRO partners. 
  • Collaboration with colleagues to ensure methods are appropriately validated to support GLP studies 
  • Troubleshooting and resolving technical issues associated to ligand binding assays as they arise 
  • Actively contribute to ensuring GLP and GCP quality systems are compliant with regulatory requirements and robust scientific practice. 
  • Actively promote transfer of scientific knowledge amongst peers and keep abreast of latest developments in regulatory bioanalysis including technologies and publications.   

Education, Skills and experience:   
  • BSc./MSc. in Life Sciences (e.g. Biomedical Sciences, Medical technology, Immunology or similar) 
  • A minimum of 5 years’ experience working in the pharma or CRO industry supporting regulatory bioanalysis of NBE or biomarkers programs 
  • Hands-on knowledge of a range of bioanalytical techniques and platforms including but not limited to ELISA, MSD and Gyros to support the analysis of Pharmacokinetic and Pharmacodynamics endpoints including Anti-Drug Antibodies and Biomarkers. 
  • Experience in autonomous method development and validation and transfer of novel methods for PK, ADA and Biomarker support. 
  • Ability to troubleshoot immunoanalytical methods to ensure methods are fit for purpose. 
  • Experience in working with a wide range of internal stakeholders including Non-Clinical Safety, DMPK, Translational Medicine, Clinical Pharmacology, Clinical operations and Quality Assurance colleagues.   
  • Well organized, capable of communicating clear instructions to partners and stakeholders alike 
  • Good knowledge of the English language both written and spoken, working knowledge of French is a plus 
  • Experience utilizing automation tools such as the Hamilton Starlet or other systems would be highly desired  
    
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