Drug Devices Development Specialist

Pharmathen

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Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.Due to continuous growth and expansion, Pharmathen offers a great opportunity for career development and is seeking to attract a Drug Devices Development Specialist for the Drug Devices Development department in our Metamorfosi premises.As a Drug Devices Development Specialist, the ideal candidate will provide high quality support in analytical development / product life cycle in a GLP environment.RequirementsMore particularly:What you will do:

Define the specifications of the materials and medical devices for the intended applications in interaction with QA/Clinical/RA/technology transfer teams
Identify/evaluate the potential MD partners (suppliers, labs, manufacturers, and engineering companies), support QA, QM, Legal and Procurement teams to qualify the selected ones and set in place the development agreements
Supervise the development activities of the customized packaging materials and medical devices assigned to external MD partners, production sites and testing labs
Work in close collaboration with the RD (formulation and the analytical), Technology Transfer and Production teams on the in-house development, testing and manufacturing activities (e.g., testing, productions/packaging)
Interact with the clinical team on the design of the human factor studies, review and approve of the HF study protocols and reports
Prepare, review and approve study protocols and plans on the manufacturing/production activities, functionality and in vitro testing of the materials
Work closely with the Procurement group for the on-time procurement/delivery of the needed quantities/materials for all testing and manufacturing activities (in house and outsourced)
Review and approve study protocols and reports from external CROs for outsourced studies on the medical devices or combination products
Compile the technical files and the DHFs of the combination products for regulatory submissions
Support commercial teams in matters related to market complaints
Contribute to the process for acquiring CE mark authorization of custom medical devices
Guide/train the level entries in the field

The ideal candidate should have:

BSc Degree in Mechanical/Chemical/ Biomedical Engineering
MSc Degree in a relevant field will be considered an asset
At least 3 years of experience in a relevant position within the Medical Device - Pharmaceutical industry
Excellent communication in English language (writing & speaking)
Computer literacy

Job-Specific Skills:

Proven Experience with Medical Devices/Combination products quality standards, documentation and regulatory affairs issues will be considered a strong asset
Problem-solving skills
Competent in lab instrumentation
Demonstrated ability to work on multiple projects and meet timelines

BenefitsWhat you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Pharmathen