• 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