Senior Scientist Bioanalytical

Il y a 5 mois


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 immunogenicity strategies for our clinical development programs, providing scientific oversight of bioanalytical vendors. Additionally, they will contribute to drafting bioanalytical and immunogenicity sections in regulatory documents. Consequently, proficiency in both scientific and regulatory requirements related to immunogenicity assay development and validation is essential. Strong communication skills are a must, along with expertise in PK and PD assay development and validation.

**Responsibilities**:

- Develop and implement the bioanalytical strategy in close collaboration with cross-functional team members, serving as a key member of project/indication teams.
- Act as an expert in immunogenicity assays, ensuring validation strategies align with regulatory guidelines and industry best practices.
- Collaborate with sourcing and program managers to oversee the timely commissioning of validation packages and bioanalysis of clinical trials by external bioanalytical vendors. Participate in vendor governance meetings as needed.
- Take responsibility for immunogenicity assay development and provide scientific oversight during transfer and validation processes with external bioanalytical vendors.
- Serve as the bioanalytical study monitor, overseeing bioanalytical study phases of clinical trials, reviewing sample analysis plans and reports, and offering input into clinical trial documents (e.g., Protocol, Data Transfer Agreement, lab manual).
- Work closely with Medical Writers to draft bioanalytical modules and immunogenicity sections in regulatory documents (e.g., Clinical Study Report/Integrated Summary of Immunogenicity/Module 2 documents).
- Contribute to interactions with regulatory agencies.
- Present results and findings at internal multidisciplinary project and clinical teams meetings.

Profile
- Ph.D. degree or equivalent experience.
- Minimum of 5 years of industry experience in bioanalytical sciences.
- Strong expertise in immunogenicity assay development/validation and/or immunogenicity risk assessment, along with proficiency in clinical immunogenicity data interpretation, including regulatory requirements.
- Thorough understanding of the development and validation of bioanalytical assays for PK/PD of large molecules, including relevant regulatory guidelines.
- Extensive (hands-on) experience with ligand binding assay methods and platforms.
- Experience in managing outsourced activities.
- Excellent communication and interpersonal skills, with a passion for collaborating in multidisciplinary teams and with external partners.
- Proficient in regulatory writing and report writing.
- Strong problem-solving skills.
- Strong emphasis on quality.
- Ability to work independently.
- Proactive and flexible, capable of thriving in the dynamic environment of a fast-growing biotech company.

Offer
- A full time position in a successful, dynamic, rapidly growing biotech company.
- A competitive salary package accompanied by comprehensive benefits.
- Exposure to all aspects of pre-clinical and clinical development in the company, but also with external vendors, contract partners and the scientific world.
- Open to remote work with regular days spent working in the Zwijnaarde (Ghent) office.

Onsite LI



  • 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...

  • Scientist Bioanalytics

    Il y a 7 mois


    Gent, Belgique Argenx Temps plein

    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,...


  • 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

    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,...

  • Cmc Scientist

    Il y a 5 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 bolster our bioanalytical team, we're seeking a Senior Research Associate with a background in bioanalytical laboratory work. This position is based in Zwijnaarde (Ghent) and daily onsite working is required. Work description Your responsibilities include: - Contributing to the development of bioanalytical assays (ELISA, MSD, Gyros platforms) for...

  • Senior Scientist Cmc

    Il y a 5 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 6 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 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...

  • Senior Data Scientist

    Il y a 5 mois


    Gent, Belgique Verotech Temps plein

    **About**: Are you interested in working in the **Steel industry**? We’re VeroTech, a Belgian engineering consultancy company specialized in R&D projects, currently looking for talented engineers. **Your mission**: As a **Senior Data Scientist**, you play a pivotal role in **managing business interactions** and **spotting opportunities** to leverage...

  • Associate Scientist

    il y a 2 jours


    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,...

  • (Senior) Data Scientist

    Il y a 5 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...

  • Senior Data Scientist

    Il y a 5 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

    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...


  • 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...

  • Sr. Crop Scientist

    Il y a 2 mois


    Gent, Belgique Inari Agriculture Temps plein

    **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...


  • Gent, Belgique BioLizard Temps plein

    **Job description **Single cell bioinformatics scientist** **Who are we?** BioLizard is a growing consultancy company providing data science solutions for our customers in biotech and pharma. Typically, a lizard adjusts to its surroundings and that is exactly what we do. At BioLizard we adapt to our customers’ data environment! The research field is...


  • Gent, Belgique Argenx Temps plein

    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,...