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.

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

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.

LI-onsit

• 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 team