Packaging / Medical Device development Project Leader

Switzerland, Project Duration: 1 Year
Location:
City: Basel
Country: Switzerland

The successful candidate for this position will need to be able to lead the technical development of packaging and/or drug delivery systems within Novartis Global Device Packaging Development Department, 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.

Tasks and responsibilities would typically include:
  • Thorough project planning and execution
  • 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

Requirements:

  • Bachelor’s or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education.
  • 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
  • Fluency in English language incl. technical writing. 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 desired:

  • Good understanding of pharmaceutical development in general
  • Experience in project / program management of complex projects
  • Good experience of managing external suppliers
  • Mechanical engineering in general
  • Product design/Design for manufacture
  • Test and verification, incl. development of methods and equipment
  • General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements
  • Good communication and conflict solving skills