Senior Expert - Medical Device Analytical Representative (m/f/d)

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

The Technology and User Services (TUS) group in NX is driven to help users use tools effectively to improve productivity and foster innovation. We deliver the Technology and User Services (TUS) group in NX to help customers use tools effectively to improve productivity and foster innovation. Our organization is here providing the technology backbone and devices that enable users to work in an office, lab or mobile environment.

Senior Expert - Medical Device Analytical Representative (m/f/d)

We are searching for a Senior Expert - Medical Device Analytical Representative with combination product development experience to lead the creation of strong analytical data-packages.

As a member of the global Chemistry Manufacturing Control (CMC) analytical sub team and device sub team for your project(s) you will be the main contact & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all levels (from component to drug product to final product), especially for injectables like Biologics, Ribonucleic Acids, Radio-Ligands (peptides).

Key Responsibilities:

• As a member of global CMC analytical subteam and device subteam for your project(s), you are the contact person & coordinator for all project-specific analytical tasks related to functional/mechanical attributes of drug-device combination products at all levels (from component to drug product to final product); plan resource & budget for your project(s).
• Select testing laboratory inline with resource availability, capability and in/outsourcing strategy, e.g. GDPD, QC, CRO; lead outsourced analytical project activities at CROs and contribute to manage external partnership.
• Own drug-specific analytical methods (AMs) / parameter sheets (PSs) for functional attributes like activation and injection force, time, volume, sound, as well as (needle) safety features, organize and align x-functional inputs (e.g. with Device/Pack Tech); define, organize, document AM/PS validation and transfer.
• Co-shape and co-author x-functional analytical CMC strategies and documents, e.g. drug product and final product stability strategy, protocols and reports, method validation and transfer status summaries, Analytical Specifications (AS); organize input to Justification of Specification JoS (from Device/PackTech and HFE).
• Contribute to and review regulatory documents, support product registrations incl. present at inspections with minimal support by Leader or assigned to moderately complex projects.

Essential Requirements:

• Master or PhD in engineering or chemical/bio analytics or equivalent and some working experience in pharmaceutical industry in combination product development.
• Proven knowledge in late phase parenteral analytical development; leadership experience in managing development projects, ideally in a global matrix environment, understanding and awareness of regulatory guidelines for combination. product analytics, experience with cGMP and relevant ISOs
• Collaborative spirit, self-driven attitude, high level of learning agility.
• Proficiency in English (written and spoken).