Senior Packaging and Device Expert to Galderma

About Galderma

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven innovative solutions for the skin. For more information, please visit www.galderma.com.

Job description

Do you want to be part of a business that contributes to human health and well-being? Do you want to work as a Packaging & Device Expert in a global organization that is currently in an exciting and expansive phase? Then this can be the role for you!

The R&D Product Development Department have employees both in Uppsala, Sweden and in Lausanne, Switzerland. Within this department the Packaging & Device Development is responsible for leading both the operational and the strategic development of packaging and devices within projects and other cross-functional teams. In Uppsala a team of 10 people are working mainly with the aesthetic products but also supports the Pharmaceutical development. This team now looks for a senior device expert to support in firsthand a project team in Lausanne, hence the location can be either in Uppsala or in Lausanne.

As a packaging & device expert you are responsible for design packaging and medical device technology in accordance with the Global R&D strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients and health care professionals needs.

You 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.

Job responsibilities

As a senior device expert, you will:

* 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 (Auto Injectors, Pre-filled syringes, etc).
* 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 and 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.

Minimum requirements

Education and Experience requirements

* 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, CMO).
* 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





Your application

We welcome your application (CV and letter) via this site or via our company website https://www.galderma.com/job-search. Apply as soon as possible though no later than 2021-02-17. The selection process is ongoing.
Should you have questions about this opportunity you are welcome to contact recruiting manager Linda Ylvén, Manager Packaging & Device Development, +46 768 981217.

We wish to inform applicants that Galderma can conduct pre-employment security checks for specific positions or activities. This security screening is performed by an external supplier after approval from applicants. We do not wish to be contacted by recruitment agencies for this recruitment at this stage.