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At Lonza, talented people work together to devise ideas that help businesses and people, with opportunities to own their careers and make a genuine impact on the world.
Tasks
- Serve as the primary point of contact between QC customer and CSM for authoring, revising, and reviewing GMP reference standard qualification protocols and reports, primarily for biotechnological reference materials.
- Ensure timely completion of qualification protocols and reports to enable LIMS/LES-related activities (MLP specifications, test schedules) and provide support.
- Provide technical mentoring and coaching to colleagues within and outside the team in a matrix environment.
- Support quality documentation and change management process for reference standards, including review, revision, and timely completion of Trackwise records.
- Lead innovation projects within the area of responsibility and identify opportunities for cost and efficiency optimization.
- Provide SME input for project-specific topics during audits and inspections.
- Ensure compliance with quality, data integrity, and safety requirements.
- Collaborate with QC project leads, QA Analytics, and external clients.
Requirements
- Master’s degree or equivalent experience in a Life Sciences discipline (Biology, Chemistry or related field).
- Proven experience in a cGMP environment; experience in quality control or analytical development preferred.
- Exceptional technical writing skills.
- Advanced scientific experience in analytical chemistry/biology.
- Extensive knowledge with QC relevant software (e.g. LIMS/LES, DMS, Trackwise, Statistica).
- Team player.
- Change readiness.
- Proficiency in English required; proficiency in German preferred.
- Excellent project and time management skills.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.