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.
Project Leader / Packaging & Device
- 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.
Have we raised your interest? Are you taking initiatives? Do you like to work in a multidisciplinary team? We are looking forward to receiving your detailed application including motivational statement, copies of your degree as well as any work certificates through our online career portal. You can track your application status online at any time: tms.altran.com. Good luck!
Mr Maxime Kapps
+41 61 225 43 06