Project Leader / Packaging & Device
ALTRAN
Basel, CHE , Suisse
vor 28 Tg.

Notre offre

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.

Vos responsabilités

  • 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
  • Votre profil

  • 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
  • LI-MK1

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