Device & Packaging Senior Expert – 6650 ADA
Our client is a leading global player in the Pharmaceutical industry with a focus on novel therapies in Oncology and Ophthalmology, and ongoing development in Neuroscience and Dermatology. The role is based in Basel, Switzerland and is an onsite 12-month contract (which will be extended).
The successful candidate will 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. A strong technical background in pharmaceutical packaging and drug delivery medical devices is required to support, monitor and challenge internal and external development partners.
Responsibilities
* Thorough project planning
* Define product requirements and qualification of oral packaging and drug delivery systems (e.g., drug/device combination products and medical devices)
* Collaborate with other development partners: monitor work progress, monitor and challenge technical development and test/verification work, and monitor 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 the manufacturing of clinical material and production scale-up
* Support cross-functional project teams in the development, review and submission of regulatory dossiers
* Manage and monitor Human Factors Engineering activities
* Monitor design verification activities (in-house)
* Lead and author technical documentation and ensure a high-quality Design History File
* Transfer 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 equivalent
* 7+ years’ experience supporting or leading pharmaceutical packaging or drug delivery device development technical teams
* Fluency in English required; German or French advantageous
* Good understanding of pharmaceutical development in general
* Experience supporting complex projects/programs
* Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive, EU Medical Device Regulation)
* Experience in development and writing of technical documentation for drug/device combination products and medical devices, including Design Control and applicable regulatory, QA and GMP aspects
* Experience with test and verification, including development of methods and equipment
* Understanding of Human Factors Engineering, risk management and clinical studies processes
* Good communication and conflict-resolution skills
Job Type
* Contract
Industry
* Pharmaceutical Manufacturing
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