Senior Design Medical Device Technology Expert Your responsibilities:

Senior Design Medical Device Technology Expert Your responsibilities:

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a senior design medical device technology expert to provide to lead, design and oversee medical device technology strategy development and packaging with pre-filled syringe or auto-injector experience.

Your responsibilities:

  • Lead and manage technical activities to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products and topical delivery systems
  • Proposes the strategy for developing human factor engineering program for combination products
  • Contributes to develop early and late phase packaging and medical devices (e.g. delivery system for combination products)
  • Proactively contribute to implement regional regulatory requirements and guidelines that impact packaging and medical device activities in close cooperation with Pharmaceutical Development Expert
  • Interact closely with external partner to ensure selection of packaging and medical devices
  • Contributes to implement, with internal partners and external partners, scientific programs to ensure adequacy of the packaging and medical device solutions: leachable & extractible studies, shipment studies
  • Author, review and/or approve key documents such as development reports, validation reports, and relevant sections of regulatory filings (IND, IMPD, CTD)

Your profile:

  • PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10 years of relevant experience in pharmaceutical/medical device industry
  • You have excellent knowledge of Established track record of success with combination products development programs
  • You have demonstrated a successful experience with external partners
  • You have excellent knowledge in developing primary and secondary packaging, medical devices
  • You have excellent knowledge of cGMP, 21CFR820, ISO13485, ICH guidance’s, ISO standards and applicable guidelines
  • You have demonstrated a successful experience related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions
  • You speak and write English fluently

For more details, please contact Marine Dollat at mdollat@axepta.com

Marine Dollat mdollat@axepta.com