Analytical Expert – Medical Device R&D (m/f/d)

Aequor Consulting GmbH; Basel; On-site; CHF 110,000 - 170,000; Full time

Benefits offered by this job

Vacationary leave

LinkedIn Learning access

Certifications funding

Reka Card contribution

Fitness contribution

Job summary

Aequor Consulting GmbH in Basel seeks an experienced Analytical Expert to lead analytical activities across medical device projects. You will drive method development, transfers, and statistical analyses while coordinating with internal teams and external laboratories.

The role involves regulatory documentation support, project registrations, and participation in inspections. Strong English communication and knowledge of ISO/Ph. Eur./USP are essential.

Qualifications

• Extensive expertise in ISO standards, Ph. Eur. and USP interpretations.
• Strong expertise in analytical mechanical testing methods for medical devices.
• Proven experience in analytical method development and transfers to internal and external labs.
• In-depth knowledge of statistical data analysis and proficiency with statistical software (Minitab).
• Excellent coordination and communication with cross-functional teams and external labs.
• Experience coordinating outsourced analytical activities and regulatory documentation.

Responsibilities

• Act as the single point of contact for analytical activities related to medical device testing within projects.
• Oversee and lead analytical activities across projects, ensuring alignment with objectives and customer requirements.
• Develop project-specific analytical methods and transfer them to internal and external laboratories.
• Select testing laboratories based on resources and capabilities; define insourcing vs outsourcing strategy.
• Lead outsourced analytical activities at external labs and manage partnerships across two projects.
• Coordinate analytical activities with cross-functional device project teams and stakeholders at drug product level.
• Support regulatory documentation preparation and project registrations.
• Assist regulatory inspections and present analytical activities and documentation.
• Conduct and oversee statistical data analysis to support decision-making.

Skills

Statistical data analysis

Analytical method development

Method transfer to labs

Minitab

Coordination & communication

ISO standards interpretation

Tools

Minitab

Job description

Are you an experienced analytical specialist with a strong background in medical device testing, analytical method development and statistical data analysis? Do you have in-depth knowledge of international pharmaceutical standards and enjoy coordinating complex analytical activities across multidisciplinary project teams and external laboratories?

For a leading international pharmaceutical company in Basel, an experienced Analytical Expert (m/f/d) is sought to support Research & Development activities within the Medical Device area. In this role, you will take responsibility for analytical activities across assigned projects, contribute to regulatory documentation and ensure the successful development, transfer and execution of analytical testing methods in both internal and external laboratory environments.

Responsibilities

• Act as the single point of contact for all analytical activities related to medical device testing within assigned projects.
• Oversee and lead analytical activities across assigned projects, ensuring alignment with project objectives and customer requirements.
• Develop project-specific analytical methods, including the transfer of methods to internal and external laboratories.
• Select suitable testing laboratories based on resource availability, technical capabilities and the applicable insourcing or outsourcing strategy.
• Lead outsourced analytical project activities at external laboratories and contribute to the management of external partnerships across two independent projects.
• Coordinate analytical activities with cross-functional device project teams and stakeholders at drug product level.
• Contribute to the preparation and review of regulatory documentation and support project registration activities.
• Support regulatory inspections, including the presentation and explanation of analytical activities and relevant documentation.
• Perform and oversee statistical data analysis to ensure reliable analytical results and support project-related decision-making.

Requirements

• Extensive expertise in international ISO standards, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP), including their interpretation and practical application.
• Strong expertise in analytical mechanical testing methods and their practical application within the medical device area.
• Proven experience in analytical method development and method transfers to internal and external laboratories.
• In-depth knowledge of statistical data analysis and strong practical experience with statistical software, particularly Minitab.
• Excellent coordination and communication skills, with the ability to collaborate effectively with cross-functional device project teams and stakeholders at drug product level.
• Experience coordinating external laboratories and managing outsourced analytical activities is highly advantageous.
• Understanding of regulatory documentation and project registration activities within a regulated pharmaceutical or medical device environment.
• High level of motivation, resilience and ability to manage a demanding workload while consistently delivering high-quality results.
• Excellent verbal and written English communication skills.
• Experience with or access to NRV, GLIMS and 1-QEM (Novartis internal systems) is considered an advantage.
• Availability during European working hours to ensure effective coordination of work packages and project status updates.

Benefits

• 5 weeks of annual vacation based on a 40-hour working week.
• Access to LinkedIn Learning with more than 5,000 online courses.
• Financial support for professional certifications and further education.
• Reka Card contribution of 20%, up to CHF 2,400 per year.
• Annual fitness contribution of CHF 400.