BioAgilytix

Technical Writer

• Assist in the management of clinical projects supported by 360biolabs
• Prepare clinical study associated reports and documents to support R&D and NATA accreditation
• Maintain high levels of communication with colleagues and maintain productive relationships with clients, CROs, collaborators and partners
• Adhere to ISO/IEC 17025, OECD Principles of Good Laboratory Practice, 360biolabs’ Quality Management System, SOPs, and other accreditation/regulatory guidelines
• Liaise with colleagues to ensure study activities are delivered consistent with Work Order timelines
• Maintain records to levels consistent with relevant standards
• Prepare and review reports related to assay validation, assay qualification, laboratory manuals, analytical protocols and study reports
• Perform data analysis and provide clear interpretation of data to others
• Produce reports for internal use and communication to clients
• Attend meetings associated with clinical research and participate in professional development and training

Analyst

• Planung, Durchführung und initiale Auswertung immunologischer Testverfahren im Labor (z. B. ECL (MSD), ELISA, zell-basierte Assays)
• Akkurate Dokumentation von Versuchsplanung und Ergebnissen
• Beteiligung als Analyst in verschiedenen Studienphasen (Validierung, Probenanalyse nach GLP/GCP)
• Beteiligung am Troubleshooting von Assays
• Erstellen von technischen Standardarbeitsanweisungen (SOPs)
• Ansetzen von Puffern, Reagenzien und Lösungen
• Geräteverantwortlichkeiten
• Allgemeine Laborarbeiten

Technical Writer

Analyst / Technische Assistenz