Tubulis GmbH

QC Manager

Tubulis GmbH

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇩🇪 Germany

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Job Level

Mid-LevelSenior

About the role

  • 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.
  • Good proficiency in spoken and written English.
  • German spoken at B1 level.
  • Preferred Qualifications: ADC experience; linker payload experience.
Benefits
  • 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
stability studiesanalytical method qualificationanalytical method validationmethod transferdata interpretationresult documentationspecifications developmentcomparability studiesGMP processesbiopharmaceutical laboratory experience
Soft skills
precisionanalytical senseteamworkcommunication
Certifications
B.Sc.M.Sc.
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