Medical Device Packaging Expert - Pharma

In this role, your mission is to lead, design and oversee packaging and medical device technology development in accordance with the strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients, health care professionals and payers’ needs.
You will lead, design and oversee 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.

Your responsibilities:

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 combination products and topical delivery systems
• Develop early and late phase packaging and medical devices (e.g. delivery system for combination products)
• 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, shipment studies
• Contribute to define strategy for developing human factor engineering program for combination products and oversee the execution
• Actively scoot new packaging and medical device technologies
• Author, review and/or approve 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

Your profile:

• PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field
• At least 10+ years of relevant experience in pharmaceutical/medical device industry
• Established track record of success with 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, medical devices
• Excellent understanding of cGMP, 21CFR820, ISO13485, ICH guidance’s, 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