Click here to know more about GSK Biopharm. #GSKBiopharm_Development Device Innovation - Director GSK's Packaging and Device Design and Development team is charged with the delivery of robust, patient-centric devices and primary packaging solutions to enable the effective delivery of novel bio-/pharmaceuticals across all modalities and routes of administration. Our group is a multi-skilled team of Engineers, Scientists and Designers who work across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection and, ultimately, the registrational submission and commercial supply. We are looking for an enthusiastic, curious and experienced device development engineer to lead a device technology and innovation team focused on (1) resolution of design, development, manufacturing and regulatory challenges, (2) identification of next-wave technologies to support GSK's future portfolio and (3) technology exploration / assessment projects in alignment with company strategy and specific pipeline needs. The successful candidate must maintain awareness of the technology and innovation landscape and be capable of supporting due diligence projects. He/she must also have both the curiosity and drive to ideate, develop and present innovative solutions along with their risks, timelines and investment requirements. Following successful candidacy, you will join a dynamic and growing team based in Upper Providence, Pennsylvania (US) and Hertfordshire, Ware (UK) that are key to delivering an expanding portfolio. The role is to be based at GSK's R&D site in Upper Providence, Pennsylvania (US) and can offer flexible hybrid working. Occasional travel may also be required. In this role you will: Lead the device innovation team comprised of device engineers and scientists with the scope defined above. Have accountability for device technology scouting and feasibility / gap assessment in partnership with device development colleagues. Have accountability for development and deployment of relevant functional device models. Serve as a key device subject matter expert to inform technology options, technology selection and probability of technical success of options under evaluation. Collaborate with colleagues in early concept, primary packaging, and full device development to understand problem statements, initiate technology scouting and determine probability of success for technologies under consideration. Work across existing and / or novel platform devices. Collaborate with multi-disciplinary teams across GSK, innovator companies and academia. Ensure that technology readiness risks, timelines and investment requirements are properly assessed and communicated. Ensure proper scope, design, and management of external innovation projects and collaborations with innovator companies and universities. Identify opportunities and propose potential mitigations during participation in design reviews at critical stages of device / product development. Inform and ensure support and / or conduct of feasibility assessments involving prototyping and lab testing activities. Develop team members, propose development opportunities and provide input during appraisals. Participate in due diligence projects. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: B.S., M.S. or Ph.D. Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemical Engineering, Package Engineering or related degree with a minimum of 10 years of industry experience. Experience with development of drug-device combination (DDC) products or medical devices and delivery technologies. Experience of working within device regulatory requirements and industry processes such as design controls (21 CFR 820.30), EU MDR 2017/745, risk management (ISO 14971), QMS (ISO 13485) and GMP. Preferred Qualifications: If you have the following characteristics, it would be a plus: Awareness of device and primary packaging technology landscape and innovations. Experience in drug device combination for large and small molecules including long-acting injectables, pre-filled syringes, autoinjectors, on-body injectors and / or novel devices for delivery of complex formulations. Awareness of regulatory pathways for combination products and software. Experience of human factors / usability engineering (IEC 62366). Team and / or matrix leadership experience. Experience with the development of connected devices. Ability to quickly establish relationships with internal and external stakeholders. Working experience of managing multiple projects of varying complexity simultaneously. Ability to synthesize and explain complex topics to non-experts and to management. Ability to work in a complex matrix environment and to influence and lead others without hierarchical authority. Strong time management / organizational skills. Evidence of team working skills and flexibility. Why GSK? Uniting science, talent, and technology to get ahead of disease together At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK gskbiopharm_development If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. 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