Novartis seeks a Senior Expert in Device Project Leadership for its Combination Product Portfolio in Basel. This role leads cross-functional teams for Cell & Gene Therapy and Radioligand Therapy projects within a hybrid work model.
Positioned within the Portfolio & Customer Center of Global Device and Packaging Development, this senior role focuses primarily on Cell & Gene Therapy and Radioligand Therapy initiatives. The incumbent serves as the central liaison for all device and packaging matters, ensuring strategic alignment and technical execution across complex therapeutic areas.
Responsibilities
- Act as the primary representative for Global Device and Packaging Development within CMC sub-teams, guiding device-related discussions and obtaining approval for project strategies.
- Serve as the single point of contact for device and packaging issues, leading cross-functional project teams to ensure cohesive progress.
- Oversee project planning, including the management of resources, timelines, and financial budgets.
- Determine and negotiate internal and external resource requirements while maintaining comprehensive documentation within the Design History File.
- Guarantee adherence to internal processes and current regulations, including Design Control, CMC standards, FDA combination product rules, and ISO requirements.
- Identify and assess appropriate device technologies suitable for various stages of project development.
- Contribute to the enhancement of process methodologies and delivery technology approaches.
- Provide support for internal and external audits concerning packaging and medical device compliance.
- Assist teams in preparing regulatory dossiers and addressing inquiries from health authorities.
Requirements
- Master’s degree or PhD in natural sciences, engineering, pharmaceuticals, or an equivalent qualification.
- At least two to four years of professional experience within the pharmaceutical industry.
- Demonstrated ability to lead and collaborate effectively within cross-functional teams in a matrix environment.
- Strong track record in project and program planning, execution, and management.
- Solid understanding of regulatory guidelines for drug-device combination products, including relevant ISO standards and current good manufacturing practices (cGMP).
- Fluent proficiency in English, both written and spoken.
Nice to have
- Prior exposure to Cell & Gene Therapy, Radioligand Therapy, or technical development of drug-device combination products.
- Proficiency in the German language.
What the company offers
- Performance-based bonus linked to specific performance metrics.
- Comprehensive insurance plans, retirement savings options, wellbeing resources, and global recognition programs.
- Flexible hybrid working arrangements where feasible.
- Minimum of 14 weeks of paid parental leave.
About the company
Novartis is dedicated to reimagining medicine through collaborative innovation. The company is committed to fostering an inclusive environment and providing reasonable accommodations to all individuals.
- Commitment to reimagining medicine together.
- Dedication to working with and providing reasonable accommodation to all individuals.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.