Associate Cmc Regulatory Scientist

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...

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...

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...

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...

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...

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...

**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,...

We are currently looking for an associate scientist with working experience in the industry to join our R&D team in our facility in Gent/Zwijnaarde. Work description **Responsibilities**: - Full time position in the lab- Discover, characterize and optimize therapeutic antibodies- Plan and execute experiments independently including interpretation and...

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...

THE COMPANY **Responsibilities**: 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...

For the expansion of our Bioanalytical team, argenx seeks a highly motivated Senior Scientist in Bioanalytics with specialized expertise in immunogenicity assay development/validation for large molecules and/or clinical immunogenicity risk assessment and data interpretation. The Senior Scientist will spearhead the implementation of bioanalytical and...

**About the role** The Regulatory Affairs Manager is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in the Benelux. Basically the RA manager...

Who we are BioLizard is a consultancy company providing bioinformatics, data science, software engineering and data management solutions for our customers in biotech, pharma and diagnostics. Typically, a lizard adjusts to its surroundings. That is exactly what we do, we adapt to our customers’ data environment! The research field is rapidly becoming more...

THE COMPANY ExeVir Bio is a young and dynamic pre-clinical stage company, working with a modular platform, developing single-domain antibody-based therapies focused on infectious diseases. ExeVir Bio has set-up a Preclinical Research Laboratory in Gent and we are seeking a highly motivated Research Associate with a Bachelor’s degree in the life sciences...

The argenx Quantitative Pharmacology and Pharmacometrics group (QCP²) looks for an experienced PK/PD scientist/modeler to support multiple aspects during pre-clinical drug development. We envision that the experienced PK/PD scientist/modeler will guide us in the pre-clinical development strategy of projects, ensuring a high quality data package supportive...

Operating under an outsourced model, argenx collaborates with bioanalytical vendors. The Senior Scientist will serve as the representative of the Bioanalytical team within one or multiple project teams, fostering close collaboration with internal and external stakeholders. Responsibilities include implementing bioanalytical strategies and contributing to...

**About Inari...** Inari is the SEEDesign company. We embrace the diversity and complexity of nature in every aspect of our business to drive innovation - to push the boundaries of what is possible. Through our unrivaled technology platform, Inari uses predictive design and advanced multiplex gene editing to develop step-change products. We are taking a...

For the expansion of our Regulatory team, argenx is looking for a Center of Excellence Regulatory Lead who is responsible for:- managing the team of regulatory associates that performs regulatory oversight for the individual studies. Key Accountabilities/Responsibilities: - Maintain an in-depth knowledge of the fast-evolving global clinical trial...

We are currently looking for a Patent Attorney to join our Intellectual Property (IP) team. The Patent Attorney closely collaborates with scientific, clinical, BD (business development) and CMC (chemistry, manufacturing and controls) colleagues. He/she will serve as the IP business partner, engaging and coordinating with external counsel as appropriate. In...