Analytical Expert Medical Device

• Act as Single point of contact for analytical activities within the project for device related testing activities.
• Creation of project specific analytical methods including transfer to internal and external laboratories.
• Selection testing laboratory in-line with resource availability, capability and in/outsource strategy for both projects.
• Leading outsourced analytical project activities at external laboratory and contribution of management external partnership for both independent projects.
• Contribution and review regulatory documents and support project registration activities including presentation at inspections for both independent
• In-depth knowledge of statistical data analysis, strong practical skills in statistical software (e.g. Minitab)
• Oversee and lead all analytical activities of assigned projects; meet customer needs

• Expert on ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP), their interpretation and application.
• Expert on analytical mechanical methods and their application
• Excellent coordination and communication skills with cross functional device project-team members as well as on drug product level In-depth knowledge of statistical data analysis, strong practical skills in statistical software (e.g. Minitab)
• Highly motivated and able to handle high workload consistently delivering very high quality.
• Specific requirements:
  English-speaking (excellent verbal and written), access to NRV, GLIMS, 1-QEM (Novartis internal systems) preferable, European working hour preferred (for alignment on working packages and status)

Start
: 01.01.2027

Duration
: 12 months

Capacity
: 5 days per week (50% on-site & 50% remote)