Associate Scientist Bioanalytics

argenx

Ghent, Belgium

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.

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

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