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