QC Scientist Analytical Technologies
vor 1 Tag
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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