Analytical Expert Medical Device

K-Recruiting Life Sciences; Basel; Hybrid; CHF 110,000 - 140,000; Full time

Job summary

K-Recruiting Life Sciences seeks a dedicated analytics project lead in Basel to drive device-related testing activities. You will develop and transfer project-specific analytical methods to internal or external labs, and oversee testing strategies to ensure quality and regulatory compliance.

Start 01.01.2027. Duration 12 months. 5 days/week with 50% on-site and 50% remote. Emphasis on regulatory support and cross-functional collaboration within GMP environments.

Qualifications

• Regulatory knowledge of ISO norms, Ph. Eur. and USP interpreted and applied.
• Analytical methods development and transfer to labs.
• Excellent coordination and communication across cross-functional teams.

Responsibilities

• Act as single point of contact for analytical activities within the project.
• Create project-specific analytical methods including transfer to internal and external laboratories.
• Select testing laboratories in-line with resource availability, capability and strategy for projects.
• Lead outsourced analytical project activities at external laboratories and manage external partnerships.
• Contribute and review regulatory documents and support project registrations including inspections.
• Oversee and lead all analytical activities of assigned projects to meet customer needs.

Skills

Regulatory knowledge

Statistical analysis

Minitab

Project leadership

Tools

Minitab

Job description

• 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

Qualification

• 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)

Requirements:

Start: 01.01.2027

Duration: 12 months

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