Scientist Bioanalytical

Scientist Bioanalytical

argenx

Gent, Belgium

For the expansion of the Bioanalytical team, argenx is looking for a 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 and strong communication skills are considered an asset.

Responsibilities:

• As a bioanalytical study monitor you are responsible for the method transfer and validation to bioanalytical 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
• Supports the development of bioanalytical strategies in collaboration with bioanalytical, project team and clinical teams.
• Initiates and follows up on troubleshooting of bioanalytical methods
• Presenting results and findings at internal multidisciplinary project/clinical teams

Profile:

• Master degree or equivalent by experience( in the field of life sciences)
• Experience in managing Contract Research Organizations (CROs) is considered an asset
• Good knowledge of bioanalytical techniques specifically in the field of biologics and antibodies
• Solid knowledge in the development and validation of bioanalytical assays including the respective regulatory guidelines (GLP and GCP)
• Hands-on experience with ligand-binding bioanalytical methods on ELISA, MSD or Gyrolab is considered an asset
• 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

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Belgium      Clinical Research      Pre-clinical Research and Development      Quality Assurance      argenx