Overview
Device & Packaging Senior Expert – 6650 ADA
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Device & Packaging Senior Expert for a 12 months’ contract (which will be extended ), based in Basel, Switzerland. It is an onsite role in Basel.
The successful candidate for this position will need to be able to support the technical development of packaging and delivery systems for new oral drugs within the Oral Packaging & Delivery Systems Group, from early phase activities up to commercialization and production scale up.
In addition to outstanding inter-personal skills, a strong technical background in pharmaceutical packaging and drug delivery medical devices is crucial to be able to support, monitor and challenge internal and external development partners.
Responsibilities
Thorough project planning
Supporting the definition of product requirements and qualification of oral packaging and drug delivery systems, e.g. drug/device combination products and medical devices
Supporting the collaboration with other development business 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
Providing 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 & the production scale up
Supporting cross functional project teams in the development, review and submission of regulatory dossiers
Leading Risk management activities
Managing and monitoring Human Factors Engineering activities
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
Qualifications
Relevant working/residency permit or Swiss/EU-Citizenship required
Bachelor’s or Master’s 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 supporting or leading pharmaceutical packaging or drug delivery device development technical teams.
Fluency in English language is required. Proficiency in German/French advantageous
Good understanding of pharmaceutical development in general
Experience in supporting complex projects / programs
Understanding of medical device regulations (FDA 21CFR 820, 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
Mechanical/Industrial 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
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