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There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
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Are you looking for a exciting position in radiopharmacy? In this role you will provide advanced manufacturing and QC analytical support to GE Healthcare's network of PET radiopharmaceutical manufacturing partners. You will take technical ownership of GE Healthcare's expanding portfolio of PET tracers, managing of existing products and consumables, resolving customer issues as well as providing technical input into new initiatives and leading delivery of projects. Join the GE team! Essential Responsibilities:
Essential Functions (Responsibilities):
Support of manufacturing sites
• PET radiopharmaceutical manufacturing/QC expert supporting multiple regions and responsible for training of all new sites
• Technical support and project management for new manufacturing sites during the technology transfer phase of products (working closely with the appropriate PET manufacturing head on setup of new sites)
• Working with GE Healthcare's team of regional field engineers to ensure a high-level of manufacturing support
• Review of site data to guarantee all data can be used within the relevant regulatory submissions and filings
• Detailed analysis of batch data to enable key learnings to be shared quickly across the whole network, continuous improvement
Technical authority and product lifecycle management Qualifications/Requirements:
• Help to develop and maintain product design files for each of GE Healthcare's proprietary PET tracers
• Plan and prioritize post-launch development of PET radiopharmaceuticals
• Give 'voice of customer' input to R&D group on the commercial manufacturing requirements for new PET tracers
• Provide support to customers and to QA for product complaints related to all PET SC products and consumables
• Generates reports, test protocols and risks assessments to support the validation of products and consumables and or quality decisions
• Leads investigations to determine route cause and put in place corrective actions and recommendations.
• Bachelor's degree in engineering or chemical engineering or equivalent knowledge and experience
• Experience working in the pharmaceutical industry
• Worked in a GMP environment.
• Product quality or supply chain experience.
• Exposure working to regulatory standards.
• Knowledge or understanding of validation.
• Technical knowledge of manufacturing processes.
• Rout cause analysis.
• Experience managing or leading a project.
• Strong communicator.
• Experience working with third-party manufacturing partners.
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
http://www.ukba.homeoffice.gov.uk/visas-immigration/working Desired Characteristics:
• Strong problem-solving abilities for remote diagnosis and troubleshooting at manufacturing sites. Locations:
• Experience working to FDA regulations
• Experience in radiopharmacy or PET
• Lean manufacturing experience
• Demonstrated ability to lead teams
• Demonstrated analytical, process management skills
Belgium, Germany, Netherlands, United Kingdom