We are recruiting for an expert in Combination Devices and Packaging development. You will lead technical development of packaging and drug delivery systems from early phase activities up to commercialization and production scale up. Using your outstanding project management skills and strong technical background in medical devices and in pharmaceutical packaging development, you will 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 need to be developed
* Leading the collaboration with external development partners: - Monitor, support and challenge technical development; test and verification work and of manufacturing processes
* Provide primary packaging and device expertise in a broader cross-functional drug product development team
* 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 and transfer of Design History File to production
* 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
* 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
* Good understanding of pharmaceutical development in general
* Experience in project / program management of complex projects
* 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
* Considerable 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
Kontakt: Luchele Mendes: +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.