Principal Material Scientist, Device and Product Performance

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Job Description - Principal Material Scientist, Device and Product Performance (2 Job Description Primary Location Organization Principal Material Scientist, Device and Product Performance - 2 For Us, It's A Mission Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Mylan to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time. Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will successful candidate will join the Device and Product Performance Group within Global Device Development as a Engineer in the Device and Product Performance group. Subject matter expert in Global Device Development on device materials including material characterisation, biological evaluation, extractable profiling and packaging studies across biological , injectable, respiratory and Dermatology products.   Material selection for device materials and packaging to enable device functionality, ensure compatibility with drug product and meet safety and efficacy requirements for the combination product.   Development of material requirements and specifications for devices ensuring compliance with the required regulatory requirements for combination products   Responsible for performing biological evaluation of medical devices following a risk-based approach in line with IS Oversight of biocompatibility testing and working with toxicology group to interpret results as required.   Responsible for performing material characterization including physiochemical testing, accelerated aging studies , in-depth literature review , extractable and elemental analysis   Responsible for ensuring extractable profiling studies are completed on device components, setting of specifications for development through to routine commercial production and linking of extractables to leachables   Author of Drug Master File for drug components and review of suppliers DMF to support device control strategy   Develop and lead device stability studies to underwrite device shelf life   Physical and Chemical Characterisation of plastic packaging and materials of construction as per relevant USP and Ph.Eur chapters   Periodic review of relevant PhEur and USP Pharmacopeia’s, EMEA and FDA guidance’s and ISO standards to ensure compliance with latest regulatory guidance and industry trends   Build testing capability to perform material characterisation to support product development by identifying external testing laboratories and develop connections with Universities and industry experts   Responsible for compilation and review/approval of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking.   Lead robust analytical method development and validation including transfer of methods to commercial sites as required   Trending and statistical analysis of analytical and manufacturing data including compilation of technical reports to support combination product development lifecycle.   Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.   Make Our Values Your Values Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position: The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment. Masters/Degree in Science with significant experience in a late stage R&D or Technical Support environment Previous experience of working as a Scientist role in a regulated and GMP environment on combination products i.e. injectable or respiratory products Expertise in material characterization including biological evaluation , biocompatibility and extractable studies is required Previous experience in compiling analytical sections of regulatory submissions and DMFs is desirable Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management. Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders Some travel will be required as part of this role Why Mylan? If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit   to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.  Copyright 2019 Mylan N.V. All Rights Reserved

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