Associate Cmc Regulatory Scientist

About our CompanyAs a prominent contract development and manufacturing organization (CDMO) in the pharmaceutical sector, Ardena is committed to aiding pharmaceutical companies, from emerging biotechs to major players, in advancing their valuable molecules to the market. Our dedication involves offering a comprehensive range of services covering drug...

argenx is a late-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique SIMPLE AntibodyTM 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...

1. PURPOSE OF THE FUNCTIONA 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 supportdevelopment and execution of regulatory strategies for marketed products in the US, EU, Japan and roll-out toother 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 and...

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 ArdenaArdena is a contract development and manufacturing organization (CDMO) focused on supporting pharmaceutical companies in bringing their molecules to the market. With a team of 500+ professionals operating across five sites in Europe, Ardena offers a comprehensive portfolio covering drug substance and drug product development, manufacturing,...

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...

For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, based in Europe, to support the rapid growth needed for successful commercialization. The role will report into the Global Head of Regulatory Affairs.Key Accountabilities and Responsibilities:The Associate Director/Director Regulatory Affairs is...

For the expansion of the Bioanalytical team, argenx is looking for a (Associate) Scientist Bioanalytics, who supports the implementation and execution of the bioanalytical strategies for the non-clinical and/or clinical development programs in tight collaboration with the project teams.Responsibilities: As a bioanalytical study monitor you are responsible...

Select Projects is op zoek naar een nieuwe collega die aan de slag wil gaan als**Associate Scientist Lab** ter versterking van ons team bij een biofarmaceutisch bedrijf in Gent.Als**Associate Scientist Lab** zal je instaan voor- Uitvoeren van analyses zoals HPLC, UPLC, capillaire elektroforese, UV-spectrofotometrie, vochtgehalte, osmolaliteit, pH, ELISA,...

About usArdena 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, logistics and...

We are currently looking for an Associate Scientist to join our team in our facility in Zwijnaarde.Responsibilities: Discover, characterize and optimize therapeutic antibodies Plan and execute experiments independently including interpret and report the results Can find a solution to any unexpected problem in a creative way Actively participate in project...

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 portfolio...

ExeVir is led by a team of experts that combines international biotech and pharma experience with a successful track record of developing and bringing products to market.PositionExeVir Bio is setting up a Preclinical Research Laboratory in Ghent and is seeking a highly motivated Associate Scientist with a Master's degree in the life sciences or medical field...

Milliken & Company werd opgericht in 1865 en is één van 's werelds grootste privé-ondernemingen in chemie- en textieltoepassingen. Wereldwijd werken meer dan 7000 Milliken collega's samen op 45 locaties verspreid over Amerika, Europa, Afrika en Azië. We worden erkend als internationale leider op vlak van onderzoek, technologie, innovatie en...

About usAs 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 portfolio...

For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA.PURPOSE OF THE ROLEThe 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 to...

THE COMPANYResponsibilities:Lead the execution of in vitro experimentsWork closely together with the Scientist to develop, optimize and qualify new assay methods, set-up preclinical in vitro experiments, analyse raw assay data and present the data to the teamContribute to literature studies in support of the R&D projectsBe in contact with supply vendors,...

argenx is actively seeking a highly motivated Senior Scientist in Bioanalytics to join our expanding Bioanalytical team. The ideal candidate will possess extensive expertise in biomarker assay development and validation for large molecules.Operating under an outsourced model, argenx collaborates with bioanalytical vendors. The Senior Scientist will serve as...