JOB DESCRIPTION SUMMARY

To provide manufacturing and QC analytical support for to GE HealthCare’s network of PET manufacturing partners in EU. Additionally, take ownership of all key projects associated with both the product process and product materials and consumables. This will include resolving On-Time Delivery (OTD) issues as well as providing technical input into new initiatives and leading the delivery of these key improvements.
GE HealthCare’s PET Supply Chain-EU is searching for a PET Advanced Application Specialist. This position’s primary responsibilities will organize and facilitate the technology transfer of GE HealthCare’s licensed radiopharmaceuticals to our selected Contract Drug Manufacturing Organizations (CDMO). This role will provide an opportunity to become part of a growing segment within GE HealthCare Pharmaceutical Diagnostics and deliver the future of precision healthcare. Candidates should expect to work within a fast-paced team that supports a range of priorities throughout each year.

QUALIFICATIONS/REQUIREMENTS

• Bachelor’s degree in chemistry / chemical engineering or similar scientific disciplineAt least 3 years’ experience working in the pharmaceutical industry (manufacturing, R&D, or technical support)
• Experience in PET tracer manufacture (cyclotrons, chemistry systems platforms, QC methodology) is essential

KEY SKILLS MUST INCLUDE:

• Strong problem-solving abilities for remote diagnosis and troubleshooting at manufacturing sites. Data analysis and statistics skills are particularly important
• Customer focus and engagement: success in the role will depend on the ability to form strong relationships with third-party manufacturing partners. Will be able to work well in an international environment.
• A high degree of autonomy is necessary, as the role might be geographically separated from the hiring manager and other advanced application team members. Able to provide scientific and technical leadership across global functions and the business.
• Will have well developed internal and external scientific or specialist contacts to draw upon
• Worked in a GMP environment. Has product quality or supply chain experience. Exposure working to regulatory standards
  The successful individual will have a strong knowledge of PET Radiopharmaceuticals and previous experience with CMOs and have a high level of technical expertise. Good knowledge of radiochemistry techniques and applications including automated synthesizers and QC analytical techniques. Strong interpersonal skills, problem solving, and an ability to work constructively with internal and external customers will be critical to the success of the product development and commercialization. The successful individual will also be expected to work independently on behalf of the core team, as well as lead, initiate and/or provide major innovative scientific input in the identification of new automated methodologies/radiotracer synthesis within.
  For this application we also evaluate candidates who meet the requirements set out in the art. 1 or belonging to the protected categories referred to in art. 18 of law 68/99

Support of manufacturing sites

• PET radiopharmaceutical manufacturing/QC expert supporting multiple sites and regions for the PET Drugs product.
• Creating and managing action plans and problem-solving reports to ensure KPIs are met.
• Technical support and project management for technology transfer projects (working closely with the EMEA PET manufacturing head)
• 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 and tracking reliability progress.
• Detailed analysis of batch data to enable key learnings to be shared quickly across the whole network, continuous improvement.
• Develop and improve technology transfer and site qualification documentation.
• Organize and lead internal and external meetings in support of projects
• Oversee transfer of automated manufacture and QC release testing of PET radiopharmaceuticals external manufacturing sites.
• Support GMP site set-up of PET radiopharmaceutical production and provide site management support as required.
• Strong customer focus. Good understanding of external partners technical capabilities and process work-flows including quality, EHS and facility infrastructure/equipment set-up.
• Project management oversight of new CMOs to meet project timelines
• Ongoing support and project management of CMO operations
• Interface with GEHC Quality Assurance on CMO remediation activities
• Assist in the design of product development activities
• Deployment of product updates and enhancements
• Review of site data to ensure accuracy for relevant regulatory submissions and filings
• Travels are required within European countries or abroad for supporting CMOs reliability

Technical authority and product lifecycle management

• 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.