(Senior) Scientist Bioanalysis

Location Ghent Zwijnaarde, United Kingdom
Discipline: Biotechnology
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10750
Published: 19 days ago
As a (Senior) Scientist Bioanalysis you will support preclinical and clinical studies by leading bioanalytical and immunogenicity work packages such as method development, method validation and sample analysis, in non-regulated and regulated GLP/GcLP setting. A high level of quality needs to be maintained. As a member of the Bioanalysis and Immunogenicity department your efforts will help deliver medicines to patients by contributing to a broad range of drug development stages.

YOUR RESPONSIBILITIES:
  • Scientific responsibility for regulated (GLP/GcLP) and non-regulated bioanalytical analyses.

  • Devise bioanalytical strategy within a project

  • Design, develop and validate PK, BM and/or ADA ligand-binding assays within regulatory and industry guidelines

  • PK, BM and immunogenicity analysis to support pre-clinical and clinical studies

  • Transfer assays internally between laboratories or externally to outsourcing partners (CRO)

  • Monitor external outsourced projects as scientific expert and sponsor contact

  • Effectively report and discuss results in project teams in a global drug development matrix environment

  • Oversee and participate in systems administration and validations

  • Author comprehensive bioanalytical study plans and reports

  • Represent the department as a functional representative on project and cross-functional teams.

  • Contribute to scientific discussions and drive technical project progress

  • Present and discuss scientific results and serve as a subject matter expert on project teams and cross-functional initiatives

YOUR 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. Relevant industry experience is a strong plus

  • Strong background in immunoassay development using technologies such as ELISA and ECL (MSD)

  • Strong knowledge of principles of bioanalysis: familiarity of current bioanalytical and immunogenicity regulatory guidance (FDA/EMA/ICH) is a plus

  • Quality-oriented - prior experience in a regulated (bio)analytical laboratory (GLP, GcLP or GMP) is a plus

  • Extensive knowledge in drug development spanning from pre-clinical to phase III

  • Excellent self-organization, time management and documentation 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

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

    INTERESTED?

    For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.