Senior Scientist DP Commercial

Responsibilities

• Provide general management and control of external vendors to coordinate drug product manufacturing activities, including sterile fill-finish, combination products, and secondary packaging.
• Manage production-related deviations and change controls both internally and with external vendors.
• Perform Life Cycle Management and continuous improvement of manufacturing processes.
• Manage drug product raw materials in collaboration with Supply Chain and external partners.
• Provide technical support for the maintenance of registration documentation and review manufacturing specifications.
• Act as a subject matter expert to support audits of manufacturing facilities in accordance with GMP and internal procedures.
• Proactively identify and track project critical path items, managing risks and monitoring corrective actions.

Requirements

• MSc or PhD in chemistry, pharmaceutical sciences, bio-engineering, or a related biotechnology discipline.
• 7+ years of relevant industry experience in a pharmaceutical or biotechnology setting.
• In-depth knowledge of ICH and GMP regulations, as well as FDA and EMA/CHMP guidelines.
• Proven experience in parenteral drug product manufacturing, including combination products and secondary packaging.
• Strong technical expertise in working within a Quality Management System (QMS).
• Fluent in English, both written and spoken.
• Willingness to travel up to 30% of the time.

Preferred Qualifications

• Experience in managing complex supply chains and external CMO relationships.
• Strong project management skills with the ability to communicate effectively with global stakeholders.
• A mindset focused on continuous improvement and technical excellence.

About the Company

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment.