Auf einen Blick
- Aufgaben: Führe analytische Tests durch und qualifiziere Methoden in einem GMP-Umfeld.
- Unternehmen: Innovatives Unternehmen im Bereich Analytik mit Fokus auf Qualität.
- Vorteile: Attraktives Gehalt, Weiterbildungsmöglichkeiten und ein dynamisches Arbeitsumfeld.
- Weitere Informationen: Teamorientierte Atmosphäre mit Möglichkeiten zur beruflichen Weiterentwicklung.
- Warum dieser Job: Gestalte die Zukunft der Analytik und arbeite an spannenden Projekten.
- Qualifikationen: Bachelor-Abschluss in Chemie oder verwandten Bereichen und 5+ Jahre Erfahrung.
Das prognostizierte Gehalt liegt zwischen 50000 - 65000 € pro Jahr.
Jobdescription
Your key responsibilities in this role are
- Conduct routine analytical testing, method qualification execution as well as stability in an independent manner on:
- Liquid chromatography (PA, SEC, RP, )
- Capillary Electrophoresis (ic IEF, CGE-SDS)
- Able to validate/qualify analytical methods (LC, CE especially, but knowledge of OD, LC-MS, ELISA can be an asset) in GMP environment
- Deliver data treatment/elaboration and analytical reports of high quality in a digitally agile manner.
- Interact with customers when needed, with the aim of result discussion or coordination of routine and/or validation activities.
- Works autonomously for the execution of either routine or non-routine activities within established procedures and practices that require knowledge of technical concepts or specialized technical expertise, i. e stability.
- Strong expertise in GMP environment.
- Validate GMP methods including analysis and documentation. Method validation knowledge is mandatory.
- Actively seeks, shares and re-applies knowledge in own field of activities.
- Actively recommends and leads analytical workflow improvement initiatives in a cross functional setting.
- Presents and defends relevant topics during health authority inspections.
- Ability to write GMP documentation: URS, protocols, reports, working instructions, deviations, CAPA, CCP Actions.
- Qualifikationen
Who you are
- Bachelor's degree (or equivalent) in Chemistry, Pharmacy, Biology, or Biotechnology.
- 5+ years of experience in an analytical lab within a GMP environment for CFC; or 5+ years with a Master's degree.
- Practical use and comfortable application of (G)LIMS systems; Empower knowledge is a plus.
- Ability to write GMP analytical protocols/reports/SOPs.
- Knowledge of Trackwise / Veeva / Falcon is an asset.
- Strong knowledge in LC and/or MS and/or CE, and/or OD and/or ELISA and/or dd PCR; routine testing, troubleshooting, equipment cleaning.
- Knowledge of CMC NBE/ADC development; ADC knowledge is a strong asset.
- Familiarity with GMP, Quality Systems, and international guidelines (ICH, Pharmacopoeias).
- Team player with English communication skills; French is an asset.
Wir glauben, dass du diese Fähigkeiten brauchst, um Analytical Operations and QC Laboratory Senior Technician -9 month mit Bravour zu bestehen
Communication Skills
Problem-Solving Skills
Organizational Skills
Compassion
Flexibility
Adaptability
Teamwork