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Scientist quality GMP

  • Location:

    Zwijnaarde, Belgium

  • Contact:

    Claudia Tavernier

  • Job type:

    Permanent

  • Contact phone:

    015 445 887

  • Industry:

    Biotechnology

  • Contact email:

    claudia_tavernier@oxfordcorp.com

Our client, a biotech company in Gent, is looking for a scientist in their GMP QC Lab of the Quality Department.

Job Description

You are a project lead for the GMP QC Lab. The main responsibilities are release, stability and in use testing of the pre-clinical, clinical and commercial materials under full GMP control.

Responsibilities

  • You represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert.
  • You are responsible for the qualitative technology transfer of analytical methods from a Transfer Unit to the GMP Unit, or from the GMP Unit to a Receiving Unit.
  • You are responsible for the establishment of GMP Analytical Methods (such as SEC, RPC, IEX-HPLC, CGE, CE-IEF, UV spectrometry, and potency assays (ELISA or cell based assays)).
  • You are responsible for the establishment of technical instructions of the systems used in the GMP QC Lab.
  • You perform method qualification and / or validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites.
  • You perform technical review of analytical results, assist and guide the (Senior) Research Associates in technical problem solving and conduct investigations if required.
  • You follow up on trending data and define appropriate actions if required.
  • You suggest and develop new approaches and processes.
  • You organize trainings as subject matter expert (on methods, laboratory systems).
  • You are responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab.
  • You write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory.

Requirements

  • PhD with 3 years of post-doc experience in a relevant field of life sciences or MSc, Bio-engineer with 7 to 10 years of relevant experience.
  • Fluent in Dutch and English, written and spoken.
  • You combine technical expertise with good people management skills.
  • You have experience in physico-chemical analysis and/or potency testing of proteins.
  • Experience with method validation, method life cycle management, critical reagent management, stability studies and release testing is an asset.
  • Experience with GMP guidelines and a GMP working environment.
  • Knowledge of ICH and Pharmacopeia.
  • Team player, enthusiastic, independent and self-motivated.
  • Excellent communication and writing skills are required.
  • Sense for initiative, quality, accuracy and detail.

Benefits

  • Permanent position
  • Competitive salary package