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.
Requirements
A degree in biotechnology, biochemistry, chemistry, or related subjects (B.Sc. or M.Sc.).
3–5 years’ experience in a GMP area and related processes (stability testing, method qualification/validation, changes, investigations, etc.).
Experience in a biopharmaceutical laboratory.
Precision, analytical sense, and capability to work in a team.