Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has approximately 40 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

 

(Associate) Scientist Bioanalysis - focus on Immunogenicity

The Bioanalysis and Immunogenicity department develops ligand-binding assays for research and development purposes, such as pharmacokinetic (PK), immunogenicity (ADA) and biomarker (BM) assays. The applicant is expected to support preclinical and clinical studies by leading bioanalytical and immunogenicity work packages such as method development, qualification, validation and sample analysis. Expertise developing custom immunoassays on platforms as ELISA, ECL (MSD) and other state-of-the art systems is a plus. A high level of quality needs to be maintained, excellent self-organization and documentation skills are therefore mandatory. The (Associate) Scientist will be expected to present and discuss her/his own scientific results and provide input to technical project teams.

We look for individuals who have relevant immunoassay development and qualification experience, preferably within the above-mentioned technology fields. Prior experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus.

More experienced candidates are also encouraged to apply, as entry level will depend upon this relevant experience.

Key Responsibilities Include:

  • Scientific responsibility for immunogenicity and bioanalytical analysis - can also be in a regulated (GLP/GCP) setting
    • Devise bioanalytical strategy within a project
    • Design, develop and validate PK, BM and/or ADA assays
    • PK, BM and immunogenicity analysis to support pre-clinical and clinical studies
    • If required, transfer assays internally (to GLP facility) or outsource (and follow-up) to CRO
  • Effectively report and discuss results in project teams in a global drug development matrix environment
  • Author comprehensive bioanalytical reports
  • Contribute to scientific discussions and drive technical project progress

Candidate Profile:

  • PhD in a relevant field of life sciences with immunoassay development experience (e.g. biochemistry, immunology, biology, etc.); or MSc, with 5+ years of relevant experience.
  • Strong background in immunoassay development using technologies such as ELISA and MSD,
  • Strong knowledge of immunogenicity and principles of bioanalysis: familiarity of current bioanalytical and immunogenicity regulatory guidance (FDA/EMA/ICH) is a plus
  • Quality-oriented - Prior experience in a regulated bioanalytical laboratory (GLP/GCP/GCLP) is a plus.
  • Excellent time management and organization skills
  • Strong communication (verbal, written, interpersonal, listening) skills
  • Ability to work independently with minimal supervision
  • Ability to adapt to rapidly changing priorities
  • Ability to multi-task and meet timelines in a fast-paced environment
  • Team player
  • Excellent English skills (oral and written)
  • Knowledge of MS Office (Word and Excel)
  • Available for full time position

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