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Expert Science & Technology (Device Development Engineering)


Database Development


King Of Prussia, Pennsylvania, United States

Gyroscope Therapeutic’s legacy Device Development team has become the Targeted Therapeutic Delivery Center (TTDC) within Novartis. There is a need for targeted delivery of therapeutics for many of the advanced therapies being developed, specifically ocular gene therapies. Currently this Center is focused on developing novel therapeutic delivery devices for Gyroscope’s lead investigational gene therapy, GT005. This therapy is currently being evaluated in Phase II clinical trials for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness. GT005 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of people with GA.<br><br>The newly formed TTDC team is responsible for developing state of the art medical devices and driving the evidence generation for these devices. A highly motivated individual is sought to join the TTDC as an Expert Science & Technology. The successful candidate will contribute to the development of multiple medical devices in the ophthalmic space as well as support the evidence generation initiatives driven from this group. This role will give the successful candidate the opportunity to join a rapidly growing world-class team and to play a part in shaping the growth of this exciting biotechnology company.<br><br>Your responsibilities will include, but are not limited to:<br>• New product development for medical devices and surgical instrumentation <br>• Work closely with team members within the TTDC, and cross functionally, to support and progress in-house non-clinical ophthalmology studies <br>• Identifying user needs, verifying and validating designs<br>• Performing aspects of Design Control and Risk Management activities <br>• Develop and support usability studies of the device<br>• Interact and support research activities across all functional groups at Gyroscope Therapeutics to effectively deliver on Gyroscope Therapeutics’ objectives<br>• Support in-house establishment and characterization of device data to support device claims<br>• Ability to support multiple device development projects at the same time<br>• Understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for manufacturing and GD&T <br>• Strong initiative and follow through in executing responsibilities, overcoming obstacles, and balancing multiple priorities effectively <br>• Ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams <br>• Authoring a protocols and reports<br>• Occasional travel to support surgical labs and meet with vendors<br>• Collaborate with Regulatory, Quality, and Pharmaceutical Development functions<br>• Additional duties as assigned.<br><br><br>[#video#{#400,300#}#/video#]