Packaging development Project Leader- combination devices , 12 months contract
We are now recruiting for a project leader to take charge for the technical development of packaging and/or drug delivery systems from early phase activities up to commercialization and production scale up.
Tasks and responsibilities: 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 development and implementation of manufacturing processes
Provide primary packaging and device expertise in a broader cross-functional drug product development team
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
Leading and authoring technical documentation and ensuring a high quality Design History file Transfer of Design History File to production
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
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 ( inhalation products)
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.