Senior Scientist Bioanalytics (LC-MS)

argenx

Ghent, Belgium

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.

Responsibilities

As a bioanalytical LC-MS expert for large molecules, responsible for LC-MS-based assay development, validation and sample analysis by bioanalytical vendors in support of nonclinical and clinical studies ensuring compliance with regulatory guidelines and industry best practices;
In collaboration with the sourcing manager and program manager, oversee the timely commissioning of assay development, validation and sample analysis 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 nonclinical studies and clinical 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 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

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-MS–based 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.