Overview
Proclinical is seeking a Senior Packaging & Delivery Specialist for an on-site role. This fixed-term contract position offers extension opportunities based on operational demand and funding. You will lead the design and development of packaging formats and oral drug delivery technologies, supporting the full product lifecycle from early-stage formulation through commercial manufacturing. Requires strong expertise in pharma packaging, drug delivery, and devices, with excellent collaboration skills.
Responsibilities
* Plan and manage projects thoroughly.
* Define product requirements and qualify oral packaging and drug delivery systems, including drug-device combination products and medical devices.
* Collaborate with development and business partners, monitoring progress and providing technical support.
* Oversee the development and implementation of manufacturing processes.
* Provide expertise in primary packaging and devices within cross-functional drug product development teams.
* Evaluate and challenge technical solutions.
* Coordinate the manufacturing of clinical materials and production scale-up.
* Support cross-functional teams in regulatory dossier development, review, and submission.
* Lead risk management activities and monitor Human Factors Engineering efforts.
* Supervise design verification activities and ensure high-quality Design History Files.
* Author and lead the creation of technical documentation.
* Facilitate the transfer of Design History Files to production.
Key Skills and Requirements
* Degree in Packaging Science, Mechanical Engineering, or a related field.
* Strong experience in pharmaceutical packaging or drug delivery device development.
* Fluency in English; proficiency in German or French is advantageous.
* Solid understanding of pharmaceutical development processes.
* Familiarity with medical device regulations (FDA 21CFR 820, EU Medical Device Directive/Regulation).
* Experience in technical documentation, including Design Control processes and regulatory aspects.
* Knowledge of mechanical/industrial engineering, product design, and test/verification methods.
* Understanding of Human Factors Engineering, risk management, and clinical study requirements.
* Excellent communication and conflict resolution skills.
Additional Information
Please note: to be considered for this role you must have the right to work in this location or hold an EU passport.
If you have questions, please contact Emile de Beer at e.debeer@proclinical.com.
Apply Now: If you are interested in applying to this exciting opportunity, please click 'Apply' or request a call back at the top of this page.
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