Scientist Bioanalytics - Ghent, België - Argenx

Beschrijving

argenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises, spanning neuromuscular, hematology, dermatology and nephrology, we remain science-based, data-driven and patient-focused.

For the expansion of our Bioanalytical team, argenx is seeking a Scientist in Bioanalytics to assist in implementing and executing bioanalytical strategies for non-clinical and/or clinical development programs in close collaboration with project teams.

The chosen candidate will serve as the primary representative of the bioanalytical team within one or multiple non-clinical/clinical teams, gaining exposure to various stages of drug development. They should possess a solid understanding of scientific and regulatory requirements related to bioanalytical method development and validation for PK, PD, and/or immunogenicity assays. Hands-on experience with ligand binding assays and excellent communication skills are considered advantageous.

Responsibilities

• As a bioanalytical study monitor, you are accountable for overseeing the transfer and validation of methods to bioanalytical vendors and ensuring thorough oversight of bioanalytical study phases (GLP and GCP) in non-clinical/clinical studies, working closely with the project team and the bioanalytical project manager.

• Review method validation plans and reports.

• Review bioanalytical sample analysis plans and reports for non-clinical and/or clinical studies.

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

• Assist in the development of bioanalytical strategies in collaboration with bioanalytical, project, and clinical teams.

• Initiate and follow up on troubleshooting of bioanalytical methods.

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

Profile

• PhD degree or equivalent experience in the field of life sciences.

• Strong knowledge of bioanalytical techniques, particularly in the area of biologics and antibodies.

• Solid understanding of the development and validation of bioanalytical assays, including familiarity with relevant regulatory guidelines.

• Experience in managing bioanalytical vendors is considered advantageous.

• Hands-on experience with ligand-binding bioanalytical methods such as ELISA, MSD, or Gyrolab.

• Excellent interpersonal skills, with a preference for collaborating in multidisciplinary teams and with external partners.

• Exceptional organizational and communication skills.

• Ability to work independently.

• Strong commitment to quality.

• Proactive and adaptable, capable of thriving in the dynamic environment of a fast-growing biotech company.

Offer

#Onsite LT