Tubulis GmbH

Manager

• Oversight and responsibility (review, assessment, and approval) for stability studies of critical reagents, ADC intermediates, drug substance, and drug product from all projects within Tubulis.
• Support phase-appropriate analytical method qualification/validation at contract manufacturing organizations and support method transfer.
• Interpretation of in-house analytical data, including result documentation/certification, for both internal and external material according to our platform.
• Handling of changes, deviations, and OOX.
• Contribute to specifications for intermediates, drug substance, and drug product.
• Contribute to comparability studies.

QC Manager