Senior Scientist Bioanalytics; LC-MS

Position: Senior Scientist Bioanalytics (LC-MS)
Location: Town of Belgium

Senior Scientist Bioanalytics (LC-MS) page is loaded## Senior Scientist Bioanalytics (LC-MS) locations:
Gent, Belgium time type:
Full time posted on:
Posted Todayjob requisition :
REQ-4131
* 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  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 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…