QC Scientist Analytical Technologies

vor 1 Tag


Bern, Schweiz CSL Behring AG Vollzeit

Main responsibilities:

  • Develop and undertake experimental studies for the implementation of new methods, innovative technologies and remediating analytical challenges within CSL QC.
  • Coordinate and execute appropriate testing and experimental plans, under general guidance of Head of QCAT or delegate.
  • Support the development, qualification, validation, and transfer of methods between R&D, QC and external laboratories as required.
  • Provide subject knowledge to investigation of deviations, atypical results and method performance issues.
  • Identify, plan and execute testing requirements to complete studies with the appropriate documentation and presentation of results and findings.

 

Requirements:

Education

  • BSc in Biological Science or other appropriate technical field.
  • Relevant post-graduate qualification (Masters or Doctoral degree) is preferred or the equivalent industry experience (5+ years) a plus.

 

Experience

  • A minimum of 2 years’ experience in cGMP Quality Control or at least 1 years’ experience in method development for assessment of biological pharmaceutical products, or equivalent post-graduate experience
  • Experience in method development, validation and/or transfer
  • Strong technical knowledge and experience with cell-based assay, immunoassays (e.g. ELISA) and electrophoretic techniques
  • Experience with automation a plus
  • Experience in training of colleagues a plus
  • Experience with quality management, documentation system and LIMS systems a plus

 

Competencies

  • Proven written and verbal communication skills in German and English
  • Understanding of the aspects of analytical method lifecycle management
  • Good problem-solving skills
  • Ability to operate independently and as part of a team
  • Flexibility to manage changing priorities


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