Overview
Device & Packaging Senior Expert – 6650 ADA. Our client is a leading global pharmaceutical company based in Basel, Switzerland, focusing on Oncology and Ophthalmology, with a pipeline in Neuroscience and Dermatology and a strong Phase II/III program. This is an onsite role in Basel for a 12 months’ contract (with extension).
Role purpose: support the technical development of packaging and delivery systems for new oral drugs within the Oral Packaging & Delivery Systems group, from early phase activities through commercialization and production scale-up.
Responsibilities
* Thorough project planning
* Define product requirements and qualify oral packaging and drug delivery systems (drug/device combination products and medical devices)
* Collaborate with other development partners: monitor work progress, support and challenge technical development, test and verification, and oversee manufacturing process development
* Provide primary packaging and device expertise within a cross-functional drug product development team
* Evaluate and challenge technical solutions
* Support and coordinate manufacturing of clinical material and production scale-up
* Support cross-functional teams in development, review, and submission of regulatory dossiers
* Lead risk management activities
* Manage and monitor Human Factors Engineering activities
* Oversee design verification activities (in-house)
* Lead and author technical documentation and ensure a high-quality Design History File, including transfer to production
Qualifications and Experience
* Relevant working/residency permit or Swiss/EU citizenship required
* Bachelor’s or Master’s degree in Packaging Science/Engineering, Mechanical Engineering, or related field
* Typically 7+ years in supporting or leading pharmaceutical packaging or drug delivery device development
* Fluency in English; German or French is advantageous
* Strong understanding of pharmaceutical development and regulatory environments
* Experience with complex projects/programs; knowledge of FDA 21 CFR 820, EU MDR/Medical Device Regulation
* Experience in technical documentation for drug/device products, Design Control, QA, and GMP aspects
* Mechanical/Industrial engineering background; product design for manufacture; testing and verification methods
* Understanding of Human Factors Engineering, risk management, and clinical studies processes
* Good communication and conflict resolution skills
Employment type
* Contract
Location
* Basel, Switzerland (onsite)
Interested candidates should apply to be considered for this opportunity in Basel.
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