Sunday, October 26, 2025
Tubulis GmbH

QC Manager

Posted: 2 days ago

Job Description

As a member of our CMC team, you will work in the Quality Control of innovative biopharmaceuticals and be responsible for stability studies, method qualifications/validations/transfers, clinical in-use studies, comparability exercises and handling of changes, deviations and OOX investigations. As part of a project team, you will perform QC relevant activities for critical reagents, linker payload, antibody, drug substance and drug product from early to late stage in close contact with our Contract Manufacturing Organization. You will also be in close contact with our internal analytical development team for data interpretation and result certification from our analytic platform portfolio.Your missionOversight 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.Your profileQualifications: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.Good proficiency in spoken and written English.German spoken at B1 level.Preferred Qualifications:ADC experience; linker payload experience.Why us?At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.Impact that matters: Contribute to breakthrough therapies.Global mindset: Work in an international, diverse team.Grow & thrive: Develop your career in a supportive, fast-moving environment.Innovation every day: Push boundaries with cutting-edge science.At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

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