Overview

Senior Medical Device & Packaging Expert Job at Axepta SA in Lausanne, VD

Job Description



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

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

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

Job Types: Full-time, Permanent

About Company

Company: Axepta SA

Company Location:  Lausanne, VD

About Axepta SA