Associate analytical scientist Vacatures in Ghent

argenx is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE Antibody™ platform and suite of Fc engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.

To further strengthen our CMC team, we are looking for an experienced and motivated CMC scientist / senior Scientist. The scientist / senior scientist CMC will play a lead role supporting cell line development, drug substance (DS) manufacturing process development and analytical method development with external manufacturing partners (CMOs) to enable clinical manufacture of argenx therapeutic antibodies and Fc engineered molecules.

Key Accountabilities and Responsibilities :

• Supports early CMC development activities on drug candidates including : Manufacturability assessment;Formulation development;Productivity assessment;Cell line and manufacturing process (USP and DSP) development;Development / selection of appropriate analytical methods;
• Keeps oversight of cell line and process (USP and DSP) development track at CDMO and provides expert input;
• Technical review of CMC documentation (e.g. process development protocols / reports, validation, protocols / reports, stability protocols / reports, etc.) and batch manufacturing records with minimal guidance and able to draw appropriate conclusions;
• Actively (hands-on) supports the internal development of analytical methods (chromatography, bioassays, etc.);
• Proactively identifies and tracks project critical path items‚ ie identify risks and gaps, formulate, develop and monitor corrective actions and communicate risk to CMC leadership;
• As a member of the CMC (Early Development) team, actively contribute to technical and strategic discussions.
• Update project dashboards / presentations with project status to provide timely communication of status to internal team.
• Facilitate the establishment of integrated CMC operational plans with internal and external service providers by providing expert input, problem resolution definition and priority setting and oversee their execution, scope and budget.
• Work in close collaboration with quality assurance to ensure activities are performed in line with the required quality standards;
• Provides input to budget forecast cycles.

Qualifications :

3y within relevant industry

Offer :

Apply :

Your application and related information will remain strictly confidential .