Drug Devices Development Senior Officer

<p>We are one of the leading complex drug delivery and formulation developers, using our key in-house technologies to support improved patient compliance. We service a broad partner network of over 250 customers in over 90 countries throughout Europe, North America, South America, Middle East, Asia, Australia and Southern Africa.</p><p>Our portfolio consists of over 100 products, and today we are working on one of the most extensive and advanced pipelines in Long Acting Injectables, Sustained Release formulations and Preservative Free Ophthalmics, produced in our in-house US-FDA and EU-approved facilities.</p><p>We proudly employ more than 1,300 people from over 22 different nationalities across 9 locations. We welcome the opportunity to expand our collaboration with existing partners as well as to establish new partnerships, while remaining committed to our vision “to make a difference in people’s lives” through our everyday activities and our products.</p><p>Due to continuous growth and expansion, Pharmathen offers a great opportunity for career development and is seeking to recruit a <strong>Drug Devices Development</strong> <strong>Senior Officer </strong>to join our <strong>Innovative Formulations</strong> team at our <strong>Metamorfosi</strong> , Athens premises.</p><p>As a <strong>Drug Devices Development Senior Officer</strong>, the ideal candidate will be involved in all activities that concern the design and development of our combination product kits.</p><p><strong>Requirements</strong></p><p><strong>More particularly:</strong></p><p></p> <p><strong>What you’ll do</strong>: </p> <ul> <li>Prepare the technical files for the packaging systems and the DHF of the medical devices for EU Notified Body and FDA submissions </li> <li>Define the specifications of the materials and medical devices for the intended applications in interaction with QA/Clinical/RA/technology transfer teams</li> <li>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</li> <li>Supervise the development activities of the customized packaging materials and medical devices assigned to external MD partners, production sites and testing labs</li> <li>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)</li> <li>Interact with the clinical team on the design of the human factor studies, review and approve of the HF study protocols and reports</li> <li>Prepare, review and approve study protocols and plans on the manufacturing/production activities, functionality and in vitro testing of the materials</li> <li>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) </li> <li>Review and approve study protocols and reports from external CROs for outsourced studies</li> <li>Contribute to the process for acquiring CE mark authorization of custom medical devices</li> <li>Guide/train the level entries in the field</li> </ul><ul></ul><p><strong>The ideal candidate should have:</strong></p><p></p><ul> <li>Degree in Engineering (Mechanical or Chemical Engineering) / MSc studies and/or PhD in a relevant field will be considered an asset</li> <li>3-5 years of experience in a relevant position within the Medical Device industry</li> </ul><p><strong>Job-Specific Skills:</strong></p><ul> <li>Professional experience within a Quality Assurance / Quality Management department in a pharmaceutical company will be considered an asset</li> <li>Additional academic experience with Medical Devices </li> <li>Experience with Medical Devices quality standards, documentation and regulatory affairs issues will be considered a strong asset</li> <li>Excellent communication in English language (writing &amp; speaking)</li> <li>Computer literacy</li> <li>Problem-solving skills</li> <li>Competent in lab instrumentation</li> <li>Demonstrated ability to work on multiple projects and meet timelines</li> </ul> <p></p><p><strong>Benefits</strong></p><p><strong>What you'll gain:</strong></p> <ul> <li>Involvement in a high-caliber, team-oriented and dynamic atmosphere</li> <li>Exposure to challenging business issues and practices</li> <li>Great opportunity to leverage and develop your business knowledge and skills</li> </ul> <p><strong>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. </strong></p> <p><strong>Pharmathen is an equal opportunity employer. We we