Senior Scientist CMC; Early Development

Position: Senior Scientist CMC (Early Development)
Location: Town of Belgium

Senior Scientist CMC (Early Development) page is loaded## Senior Scientist CMC (Early Development) locations:
Gent, Belgium time type:
Full time posted on:
Posted Todayjob requisition :
REQ-3862
* 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.
* 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 senior Scientist. The  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:  o    Manufacturability assessment;
o    Formulation development;
o    Productivity assessment;
o    Cell line and manufacturing process (USP and DSP) development;  o    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 supports internal and external 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.
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* Qualifications:

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* • Masters / PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical / biotechnology sciences   
• Strong technical expertise in the field of biological development and drug substance manufacturing, product and process characterization  
• Strong knowledge of analytical methods (chromatography, bioassays, etc)  
• Good understanding of USP and DSP strategies  
• Expected experience: 3y within relevant industry  
• Experience with tech transfer activities is a plus  
• Desire to work in a fast-paced environment, and relevant experience in managing outsourced projects with external vendor  
• Excellent organizational and coordination skills;  
• Ability to provide attention to detail whilst keeping the…