PET Advanced Applications Specialist

Overview

PET Advanced Applications Specialist at GE HealthCare. This role provides manufacturing and QC analytical support for GE HealthCare's network of PET manufacturing partners in the EU, leads key projects related to product processes and materials, resolves On-Time Delivery (OTD) issues, and contributes technical input into new initiatives.

Essential Responsibilities

• Support PET radiopharmaceutical manufacturing / QC across multiple sites and regions for the PET Drugs product.
• Create and manage action plans and problem-solving reports to meet KPIs.
• Provide technical support and project management for technology transfer projects (collaborating with the EMEA PET manufacturing head).
• Work with GE HealthCare's regional field engineers to ensure high-level manufacturing support.
• Review site data to ensure data can be used in regulatory submissions and track reliability progress.
• Conduct detailed analysis of batch data to enable rapid sharing of key learnings across the network and drive continuous improvement.
• Develop and improve technology transfer and site qualification documentation.
• Organize and lead internal and external project-related meetings.
• Oversee transfer of automated manufacture and QC release testing of PET radiopharmaceuticals at external manufacturing sites.
• Support GMP site setup of PET radiopharmaceutical production and provide site management support as required.
• Maintain strong customer focus and understanding of external partners’ technical capabilities and process workflows including quality, EHS and facility infrastructure / equipment setup.
• Provide project management oversight of new CMOs to meet project timelines and ongoing CMO operations support.
• Interface with GEHC Quality Assurance on CMO remediation activities.
• Assist in the design of product development activities and deployment of product updates and enhancements.
• Review site data for accuracy in regulatory submissions and filings.
• Travel within Europe and abroad to support CMOs reliability as required.

Technical Authority and Product Lifecycle Management

Qualifications / Requirements

Key Skills

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Relocation

Relocation Assistance Provided : No

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