Job Detail

• Job TitleProject Leader / Packaging & Device


• Vacancy Reference Number08589


• Work SiteSwitzerland / | CHE - All Regions / Basel


• Contract TypePermanent [Full-Time]

Our offer

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. 

Your role

• 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

Your profile

• 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 

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