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von: Ctcon
Contract
Posted 1 day ago
Recruiter: Anil Dahiya
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.
Main 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 and Experience:
- 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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