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Logistics Compliance Specialist

Scientist Regulatory Bioanalysis

CMC Quality Solutions Specialist

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Project Manager Renewable Energy

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Scientist Regulatory Bioanalysis

Onbepaalde duur, Zelfstandige, Starter, Voltijds
Nog 3 dagen om te solliciteren
Brabant Wallon – Contracting

Scientist Regulatory Bioanalysis

Functieomschrijving

As a Regulatory Bioanalysis, you will focus on supporting regulatory bioanalysis across our client’s biologics portfolio.

 You will contribute by:

  • Supporting method validations and sample testing for PK and ADA assays
  • Delivering needs for pre-clinical and clinical studies
  • Work with method development scientists for the successful transfer of assays
  • Maintenance of the GLP quality system as well as being involved in optimizing and reshaping the quality system as a function of new activities, /workflows being implemented
  • Be responsible as a lab-based scientist for effective method validation and sample testing activities across multiple projects in the Immunology and CNS therapeutic portfolios

Profiel

Specific skills. competences:

Bioanalysis:

  • Extensive hands-on laboratory experience in Bioanalytical validation and sample analysis

Regulatory landscape coverage:


  • Extensive knowledge of GLP/GCP guidelines as applicable to bioanalysis
  • Extensive knowledge of bioanalytical method validation guidelines
  • Experience as principal investigator in pre-clinical and clinical studies

IT knowledge:


  • Experience using Watson LIMS or equivalent LIMS system
  • Good knowledge of Microsoft Office
  • Graphpad/JMP experience is plus



Minimum Qualifications:


  • Master’s degree with a minimum of 6 years of experience as a Bioanalytical Scientist with a proven track record in method validation and sample Testing in support of bioanalytical study phases
  • Preferably good knowledgeable in PK(LBA/LC-MS) and ADA analysis
  • Experience working in regulatory environment (GLP/GCP) where the quality is paramount would be critical
  • English thorough knowledge, both spoken and written (French will be considered as a major advantage)



Others:


  • Very good communication skills
  • Ability work cross projects/supervisors
  • Attention to detail and quality of work
  • VERY well organized, able to function in a complex fast changing environment
  • Team player
  • Proactive

Aanbod

  • Bedrijfswagen
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres

 
Standplaats
Vereisten
Professionele Bachelor (Hoger Onderwijs Korte Type) Engels

Ben je op zoek naar Productieverantwoordelijke jobs in Waals-Brabant?

Dan ben je op de juiste plaats geland, Jobat.be heeft 11 Productieverantwoordelijke jobs ter beschikking in Waals-Brabant.

De meeste Productieverantwoordelijke jobs zijn te vinden in 8710 Wielsbeke, 2250 Olen en 8400 Oostende.

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