Scientist in Aubonne

veröffentlicht
Kontakt
Coralyne Saint-Cirel, Genf Professionals Health Care & Life Sciences
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Aubonne, Genf
Sektor
Life Sciences
Jobtyp
Temporary
Referenznummer
11238
Kontakt
Coralyne Saint-Cirel, Genf Professionals Health Care & Life Sciences
Telefon
058 201 54 40
jetzt bewerben

Stellenbeschreibung

Your role: The key accountability is to support and overview bioanalytical activities (PK and immunogenicity) at CROs for development projects. You will provide scientific expertise on method development, validations and sample analysis from Preclinical to Ph3 and insure compliance with the regulatory guidelines. Coordinate and guide CRO’s to achieve timelines in cooperation with project management and clinical operations. Review of data and reports prepared by CRO’s in the context of science and compliance. Help to prepare bioanalytical sections and integrated immunogenicity summaries for submission to regulatory agencies.

 

Who you are

  • Scientific degree (MS or PhD) in Biochemistry, Chemistry, Immunology or related field
  • Industry and academic experience with development of modern bioanalytical methods for the quantitation of drugs and anti-drug antibodies in biological matrices to support drug development
  • Sound knowledge of GLP and Bioanalytical Guidance documents
  • Minimum 5-7 years of relevant experience in R&D organization of Biopharma/Biotech Company.
  • Experience and successful track record with CRO Management for bioanalytics (PK and immunogenicity)
  • Fluency in English