(Senior) Scientist Cmc Analytical Development

Il y a 5 mois


Gent, Belgique Argenx Temps plein

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 requirements;- Drives tech transfer of analytical methods between sites;- Contributing to global analytical testing strategies with internal and external stakeholders;- Supporting cross‐site analytical oversight and harmonization;- Contribute to analytical comparability testing strategies and protein characterization;- Contribute to specification setting for development, pre‐commercial and commercial stage programs;- Contributing to strategic decision making on the basis of a deep understanding of protein behavior;- Contribute to statistical trending program to support specification setting and annual product quality reviews and analytical method controls across different testing sites;- Contributes to the write up of IMPD / IND / BLA quality dossier packages and drafting responses to health agency questions.

Qualifications:
- Strong technical expertise in analytical method development, validation and protein characterization;- PhD or Master in Sciences;- Strategic and rationale thinker; able to make data‐based decisions;- Team player; able to build effective relationships with internal and external stakeholders;- Experience with writing/review of registration dossier sections is a plus (IND/IMPD/BLA/MAA);- Excellent writing skills;- Eye for detail and quality conscious attitude;- Well organized;- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines and changing priorities, flexibility is a must;- Fluent in English - our working language;

**Offer**:
- A competitive salary package with extensive benefits- Front seat in the development of therapeutic antibodies- A work environment in a human‐sized, dynamic and rapidly growing biotech company


  • Cmc Scientist

    Il y a 3 mois


    Gent, Belgique Argenx Temps plein

    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...


  • Gent, Belgique Argenx Temps plein

    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...

  • Senior Scientist Cmc

    Il y a 3 mois


    Gent, Belgique MindCapture Temps plein

    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...

  • Senior Scientist Cmc

    Il y a 4 mois


    Gent, Belgique Argenx Temps plein

    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...


  • Gent, Belgique Ardena Temps plein

    **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...


  • Gent, Belgique Ardena Temps plein

    **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,...


  • Gent, Belgique Ardena Temps plein

    **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,...

  • Cmc Project Manager

    Il y a 3 mois


    Gent, Belgique Argenx Temps plein

    Report to: CMC project management Leader Key Accountabilities and Responsibilities: - Responsible for achieving project goals, including timelines, budget, and scope. - Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between...


  • Gent, Belgique Argenx Temps plein

    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...


  • Gent, Belgique Ardena Temps plein

    **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,...


  • Gent, Belgique Argenx Temps plein

    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...

  • Senior Data Scientist

    Il y a 3 mois


    Gent, Belgique BioLizard Temps plein

    US East Coast based Who we are BioLizard is a growing consultancy company providing bioinformatics and data science 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...


  • Gent, Belgique Argenx Temps plein

    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...


  • Gent, Belgique Eurofins Belgium BioPharma Services Temps plein

    Company Description **Eurofins CDMO** is a leading international Contract Development and Manufacturing Organization (CDMO) based in Europe. Our company focuses on drug product development for chemical/biological entities and drug substance development for biologics. We support small and major biopharmaceutical companies in an innovative way to help them...


  • Gent, Belgique Ardena Temps plein

    **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...


  • Gent, Belgique Ardena Temps plein

    **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...


  • Gent, Belgique BioLizard Temps plein

    **Job description **Biostatistics & Bioinformatics scientist** **Who we are** BioLizard is a consultancy company providing bioinformatics, data science 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...

  • Patent Attorney

    Il y a 3 mois


    Gent, Belgique Argenx Temps plein

    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...


  • Gent, Belgique BioLizard Temps plein

    Who we are BioLizard is a consultancy company providing bioinformatics, data science 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 data-driven, where we...

  • (Senior) Data Scientist

    Il y a 3 mois


    Gent, Belgique Sirris Temps plein

    As the innovation companion for the technological industry, Sirris is the trusted reference for technology adoption in Belgium. We help companies to realise their innovation ambitions with hands-on support. At the heart of our services stand over 150 multi-disciplinary experts and a broad set of industrial labs spread over 8 Belgian sites, backed by the...