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Associate Scientist Bioanalytics

  • argenx
Ghent, Belgium
Full-time
Published:
  • argenx
Ghent, Belgium
Full-time
Published:

For the expansion of the Bioanalytical team, argenx is looking for a (Associate) Scientist Bioanalytics, who supports the implementation and execution of the bioanalytical strategies for the non-clinical and/or clinical development programs in tight collaboration with the project teams.

The candidate will be the key representative of the bioanalytical team in one or multiple non-clinical/clinical teams and will be exposed to different phases of drug development. He/she is considered to have solid knowledge of scientific and regulatory requirements of bioanalytical method development and validation for PK, PD and/or immunogenicity assays. Hands-on experience with ligand binding assays, LC-MS for biologics and/or flow cytometry and strong communication skills are considered an asset.

This position is based in Zwijnaarde (Ghent). Daily onsite presence is expected. Please accompany your CV with a motivation letter.

YOUR RESPONSIBILITIES:

  • Supports the development of bioanalytical strategies in collaboration with bioanalytical and project teams;

  • As a bioanalytical scientist you are responsible for the development and validation of bioanalytical methods both internally and/or in collaboration with external vendors and to keep oversight on BA study phases (GLP and GCP) of non-clinical/clinical studies, in close collaboration with the project team and the bioanalytical project manager;

  • Review of method validation plans and reports;

  • Review of bioanalytical sample analysis plans and reports of non-clinical and/or clinical studies;

  • Review and provide input in clinical trial related documents (protocol, reports, data transfer agreement, lab manual,..) as well as regulatory documents;

  • Initiates and follows up on troubleshooting of bioanalytical methods;

  • Presenting results and findings at internal multidisciplinary project/clinical teams.


YOUR PROFILE:

  • PhD in Immunology or Molecular Biology with relevant research experience or Master degree with minimum 5 years relevant industry experience in the field of life sciences;

  • Experience in managing outsourced activities at external vendors is considered an asset;

  • Solid knowledge in the development and validation of bioanalytical assays including the respective regulatory guidelines (GLP and GCP);

  • Good knowledge of bioanalytical techniques specifically in the field of biologics and antibodies;

  • Hands-on experience with LC-MS for biologics and/or flow cytometry; 

  • Understanding of pharmacology concepts of biologics, COU and fit-for-purpose biomarker assay validation, target engagement and receptor occupancy;

  • Excellent interpersonal skills, enjoys working in multidisciplinary teams and with external parties;

  • Excellent organizational and communication skills;

  • Able to work independently;

  • Strong emphasis on quality;

  • Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company.


WHAT WE OFFER:

  • A full time position in a successful, dynamic, rapidly growing biotech company;

  • A competitive salary package accompanied by comprehensive benefits, final level and remuneration are determined in function of experience;

  • Exposure to all aspects of pre-clinical and clinical development in the company, but also with external vendors, contract partners and the scientific world.

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