Associate Cmc Regulatory Scientist

Purpose of the function (Associate) Scientist CMC occupies a supporting role in Chemistry, Manufacturing and Controls (CMC) team for argenx therapeutic antibodies and their life cycle management following commercialization. Reporting Line Director CMC, analytical development Roles and Responsabilities - Follow up on the execution of agreed commercial...

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...

1. PURPOSE OF THE FUNCTION A senior scientist CMC plays a key role supporting Chemistry, Manufacturing and Controls (CMC) development of Argenx drug products, ensuring that projects move forward in time and within budget. He/she drives internal and external efforts with the aim of developing, producing and characterizing these differentiated antibody...

Key Accountabilities and Responsibilities: Leads the CMC Regulatory Affairs function within post-marketing CMC. Provides strategic leadership to support development and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out to other territories world-wide. Critical to this role are strong CMC regulatory strategy and...

SENIOR SCIENTIST CMC - Biotechnology- GhentWHAT IS OFFERED - Competitive salary package with extensive benefits. - Opportunity to contribute to the development of therapeutic antibodies and make a tangible impact on patient care. - Dynamic work environment within a rapidly growing biotech company. - Collaborative culture that fosters creativity, innovation...

**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...

To further strengthen our CMC team, we are looking for a Principal Scientist CMC Analytical Development. The Principal Scientist CMC occupies a key role supporting Chemistry, Manufacturing and Controls (CMC) development for argenx therapeutic antibodies, ensuring that projects successfully move forward within and across functions. He/she drives internal and...

**About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...

The Head of CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs will lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial phases. This role plays a critical part in ensuring compliance with global regulatory requirements while...

For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, argenx, based in Europe, to support the rapid growth needed for successful commercialization. Key Accountabilities and Responsibilities: The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role...

Key Accountabilities and Responsibilities: Contributes to the CMC development of pre‐clinical and clinical stage development programs in close collaboration with the CMC team members by: - Drives the development and validation of analytical test methods for large molecules release and stability testing in accordance with the applicable regulatory...

We are currently looking for an (associate) technical scientist or senior research associate with demonstrated working experience in antibody discovery via phage display to join our dynamic R&D team at argenx, where we strive to innovate and deliver groundbreaking medicines to patients. Location: This position is located in Zwijnaarde (Ghent) and requires...

**About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...

argenx is a fast-growing clinical-stage biopharmaceutical company developing innovative potential therapies to help improve the lives of people suffering from severe autoimmune diseases. Our global team is committed to living by our values of collaboration, empowerment, humility, innovation and excellence. As we continue to expand our therapeutic franchises,...

For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. argenx argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a...

For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA. PURPOSE OF THE ROLE The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute...

**Description Overview**: We are excited to be recruiting for an Senior Associate in Regulatory Affairs to be based in either Ghent, Rotterdam, London or Paris. Paris, France or Ghent working on our exciting Medical Device Portfolio. The main responsibilities of the role will be to work on a diverse range of Regulatory Affairs projects to meet business...

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...

For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...