Medical Device/Packaging Develoopment Project Leader

For our client in Basel we are looking for a MEDICAL DEVICE/PACKAGING DEVELOPMENT PROJECT LEADER for a 1-year contract.

PLACE: Basel

WORKLOAD: 100%

DURATION: 01/01/2018 to 31/12/2018

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 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.

Tasks and responsibilities would typically include:

.Thorough project planning and execution
. Leading the definition of product requirements for packaging, medical devices, delivery systems, eg 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
. 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
. Good communication and conflict solving skills

Additional Information:

Experience with Design Control, ISO1345, Primary Pharmaceutical Packaging Development, ideally for combination products (here: inhalation products) is important.

For more information, please contact:

Anna Chmura