Senior Packaging and Device Expert | 6 Month Contract | Remote

Location
Contact name: Tom Borchert

Contact email: tom.borchert@medella.life
Job ref: 192
Published: 3 months ago

Packaging and Device Expert | 6 Month Contract | Remote

The Opportunity:

A chance to work with one of the world's largest skincare pharmaceutical companies over the next 6 months. There is also potential for a permanent position on Site in Upsala, Sweden.

The Role:

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 fulfil patients, health care professionals and payers’ needs.

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

Operations:

  • 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.

About you:

  • 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.
Connect:

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
 
Medella Life:

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything we do.