Pet Advanced Applications Specialist

**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.

**Essential Responsibilities**

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.

**Qualifications/Requirements**
- Bachelor's degree in chemistry / chemical engineering or similar scientific discipline
At 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.
- 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

**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.

**Behaviors**

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

**Total Rewards**

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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**Additional Information**:
**Relocation Assistance Provided**:No