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 the bioanalytical team, argenx is actively looking for a highly motivated Senior Scientist Bioanalytics with extensive expertise in clinical drug development of large molecules.
The candidate will serve as the bioanalytical lead for one of the argenx compounds, represent the bioanalytical team in one or multiple project teams, and closely collaborate with internal and external stakeholders. The Senior Scientist will be responsible for designing and implementing bioanalytical assay strategies for the assigned projects.
In addition to excellent communication skills, this position requires strong knowledge of scientific and regulatory requirements related to bioanalytical method development and validation (PK/PD and immunogenicity).
The candidate should have at least 5 years of industry experience in the field of bioanalytical sciences.
Preferably, we would like to fill the position with a candidate who will be working from Ghent.
Remote work can be discussed, provided the candidate is able to be present in the Ghent office several times per month for multiple days.

Responsibilities

• Responsible for the development and implementation of the bioanalytical strategy by working closely with cross-functional team members and acting as a key member of project/indication teams.
• As a bioanalytical expert, responsible for developing assay validation strategies that comply with regulatory guidelines and industry best practices.
• In collaboration with the sourcing manager and program manager, oversee the timely commissioning of validation packages and the bioanalysis of clinical trials by bioanalytical vendors. Participate in vendor governance meetings, as appropriate.
• As a bioanalytical study monitor, responsible for the oversight of bioanalytical study phases of clinical trials, including the review of sample analysis plans and reports, and for providing input into clinical trial documents (e.g., clinical study protocols, data transfer agreements, lab manuals, etc.).
• Participate in project team meetings as a recognized bioanalytical expert.
• Collaborate with medical writers in drafting the bioanalytical modules in regulatory documents.
• Contribute to interactions with regulatory agencies.
• Stay current with relevant literature, maintaining awareness of scientific and bioanalytical developments and how they may apply to argenx clinical development programs.
• Present results and findings at internal multidisciplinary project, clinical, and bioanalytical team meetings.

Profile

• PhD degree or equivalent experience.
• At least 5 years of industry experience in the field of bioanalytical sciences.
• Hands-on experience with ligand binding assay methods and platforms; experience with LC-MS technology for large molecules is a plus.
• Experience in analyzing human samples in support of clinical trials, with a solid understanding of GCP/GCLP guidelines and other current global regulations.
• Experience in the development and validation of PK, PD, and immunogenicity assays for large molecules, including knowledge of the respective regulatory guidelines.
• Experience managing outsourced activities.
• Excellent communication and interpersonal skills, with a passion for working in multidisciplinary teams and with external partners.
• Strong regulatory writing and report writing skills.
• Exceptional problem-solving skills.
• Strong emphasis on quality.
• Able to work independently.
• Proactive and flexible, capable of thriving in the dynamic environment of a fast-growing biotech company.

Offer

• A full-time position in a successful, dynamic, and rapidly growing biotech company.
• A competitive salary package, accompanied by comprehensive benefits.
• Opportunity to be part of a cross-disciplinary team involved in the (pre-)clinical development of therapeutic antibodies.
• Exposure to all aspects of pre-clinical and clinical development, both within the company and through collaborations with external vendors, contract partners, and the broader scientific community.

LI-onsit

• Responsible for the development and implementation of the bioanalytical strategy by working closely with cross-functional team members and acting as a key member of project/indication teams.
• As a bioanalytical expert, responsible for developing assay validation strategies that comply with regulatory guidelines and industry best practices.
• In collaboration with the sourcing manager and program manager, oversee the timely commissioning of validation packages and the bioanalysis of clinical trials by bioanalytical vendors. Participate in vendor governance meetings, as appropriate.
• As a bioanalytical study monitor, responsible for the oversight of bioanalytical study phases of clinical trials, including the review of sample analysis plans and reports, and for providing input into clinical trial documents (e.g., clinical study protocols, data transfer agreements, lab manuals, etc.).
• Participate in project team meetings as a recognized bioanalytical expert.
• Collaborate with medical writers in drafting the bioanalytical modules in regulatory documents.
• Contribute to interactions with regulatory agencies.
• Stay current with relevant literature, maintaining awareness of scientific and bioanalytical developments and how they may apply to argenx clinical development programs.
• Present results and findings at internal multidisciplinary project, clinical, and bioanalytical team meetings