Are you a Senior Packaging and Device Expert?

<strong> We are looking for a Senior Packaging and Device Expert for our client in Uppsala! </strong>

<strong> Your responsibilitie as a Senior Packaging and Device Expert:</strong>
Design packaging and medical device technology development in accordance with the Global R&D strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients, health care professionals and payers’ needs. You will also design scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed life cycle management

<strong>Tasks: </strong>
• Lead and manage technical activities to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for drugs and combination products (AI, PFS…).
• Coordinate design and development activity of the packaging and delivery systems with a cross functional Team, as for example: user requirements, design input verification, risk analysis, change control.
• Ensure development or transfer of the Design History File.
• Interact closely with suppliers to ensure selection of packaging and medical devices and enhance patient/user experience.
• Develop, with internal partners (e.g. Analytical Sciences, Operations) and external partners, scientific programs to ensure adequacy of the packaging and medical device solutions: leachable & extractible studies, transportation studies.
• Contribute to define strategy for developing human factor engineering program and user test for combination products and oversee the execution.
• Actively scoot new packaging and medical device technologies.
• Author, review key documents such as: development reports, validation reports, and relevant sections of regulatory filings (IND, IMPD, CTD).
• Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact packaging and medical device activities in close cooperation with Pharmaceutical Development Expert.

<strong> Education and Experience requirements </strong>
• Mechanical Engineer, PhD in Pharmaceutical Sciences, Packaging Design and Development
• At least 10+ years of relevant experience in pharmaceutical/medical device industry.
• Established track record of success with medical devices, combination products development programs
• Experience working with external partners (e.g. Suppliers, CRO).
• Sound technical qualifications and deep knowledge in developing primary and secondary packaging, sterilization processes, transportation studies, risk analysis, new Medical Device Regulation.
• Excellent understanding of cGMP, 21CFR820, ISO13485, ISO14971 ICH guidances, ISO standards and applicable guidelines.
• Experience in authoring pharmaceutical development related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions.
• Excellent communication, negotiation and external follow-up.
• Excellent verbal and written communication skills (English)
• Ability to work in a team environment with cross-functional interactions.


Please apply as soon as poosible as selection is ongoing. Apply by registering your CV here on our website. Click on the "Ansök" button to the right. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.