The successful candidate for this position will need to be able to lead the technical development of packaging and / or drug delivery systems within the Novartis Packaging & Device Development Team, from early phase activities up to commercialization and production scale up.
In addition to outstanding project management and inter-personal skills, a strong technical background in medical devices and in pharmaceutical packaging development is crucial to support, monitor and challenge internal and external development partners.
Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g. drug / device combination products in which the device is generally already registered but sometimes to be developed
Leading the collaboration with external development partners : Monitor work progress according to plan Monitor, support and challenge technical development as well as test and verification work Monitor development and implementation of manufacturing processes
Managing the collaboration with internal development partners and stakeholders
Provide primary packaging and device expertise in a broader cross-functional drug product development team
Evaluating and challenging technical solutions
Supporting and coordinating the manufacturing of clinical material and the production scale up
Supporting cross functional project teams in the development, review and submission of regulatory dossiers
Managing and monitoring Human Factors Engineering activities
Leading Risk management activities
Planning and monitoring of design verification activities (in-house)
Leading and authoring technical documentation
Ensuring a high quality Design History file
Transfer of Design History File to production
Bachelor’s or Master degree in Packaging Science / Engineering
An ideal candidate would have a relevant degree in engineering and at least 7 years’ experience in leading device development technical teams in a similar area
Proficiency in German / French advantageous.
Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
Development and writing of technical documentation of drug / device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
Experience with Design Control, ISO1345, Primary Pharmaceutical Packaging Development, ideally for combination products (here : inhalation products) is important.
Fluent in English and German is clearly a plus