Senior Scientist Bioanalytics (LC-MS)

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.

For the expansion of the bioanalytical team argenx is actively looking for a highly motivated Senior Scientist Bioanalytics with extensive expertise in LC-MS-based regulated bioanalysis of large molecules.
The candidate will serve as the bioanalytical expert for LC-MS and oversees outsourced LC-MS-based assay development validation and sample analysis by bioanalytical vendors in support of regulated nonclinical and clinical studies for several of the argenx compounds may represent the bioanalytical team in one or multiple project teams and closely collaborate with internal and external stakeholders. The Senior Scientist will be responsible to ensure regulatory and best industry practice compliance for all LC-MS-based activities.

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).

The candidate should have at least 5 years of industry experience in the field of bioanalytical sciences.

This position is based in Belgium with the primary workplace located in Zwijnaarde (Ghent).
Please include your CV and a clear motivation when submitting your application.

Responsibilities

• As a bioanalyticalLC-MSexpertfor large molecules responsible forLC-MS-based assaydevelopmentvalidationand sample analysisby bioanalytical vendorsin support ofnonclinical and clinical studiesensuringcompliancewith regulatory guidelines and industry best practices.
• In collaboration with the sourcing manager and program manager oversee thetimelycommissioning ofassay developmentvalidationand sample analysispackages and the bioanalysis of clinical trials by bioanalytical vendors. Participate in vendor governance meetings asappropriate.
• As abioanalytical study monitor responsible for the oversight of bioanalytical study phases ofnonclinical studies andclinical trials including the review of sample analysis plans and reports and for providing input into clinical trial documents.
• 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 literaturemaintainingawareness of scientific and bioanalyticaldevelopmentsand how they may apply to argenx clinical development programs.
• Present results and findings at internal multidisciplinary project clinical and bioanalytical team meetings.

Profile

• You hold a PhD or have equivalent experience.
• You bring at least 5 years of industry experience in bioanalytical sciences.
• You have hands-on experience with LC-MS technology for large molecules (required). Experience with LC-MS for small molecules and/or ligand binding assays is a strong plus.
• You have experience developing and validating LC-MSbased PK and PD assays for large molecules and are familiar with the relevant regulatory guidelines.
• You have analyzed nonclinical samples supporting nonclinical studies and human samples supporting clinical trials with a solid understanding of GLP GCP and GCLP guidelines and applicable global regulations.
• You have experience managing outsourced bioanalytical activities and working with external vendors.
• You are a strong communicator with excellent interpersonal skills and enjoy collaborating in multidisciplinary teams and with external partners.
• You have strong regulatory and report-writing skills.
• You are a natural problem-solver with strong analytical thinking.
• You have a strong focus on quality and scientific rigor.
• You are comfortable working independently and taking ownership.
• You are proactive and flexible and you thrive 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.
• This position is based in Belgium with the primary workplace located in Zwijnaarde (Ghent). Hybrid working is possible however candidates must be based in Belgium and work from within Belgium.
  

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At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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