Supply chain Advanced Applications Specialist, Molecular Imaging

Job description

3176403
Additional Cities

Shanghai
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Global Supply Chain
Function

Manufacturing
Country/Territory

China
Additional States/Provinces

ShangHai
Postal Code

201203
Role Summary/Purpose

To provide advanced manufacturing and QC analytical support to GE Healthcare's network of PET and SPECT radiopharmaceutical manufacturing partners in China. This will include set-up of new products at the manufacturing partners, support the partners in resolving issues and challenges as well as connecting with global and local teams to share learning.
Essential Responsibilities

Essential Functions (Responsibilities):

Support of contract manufacturing sites
• Technical support – primarily QC but also manufacturing - for new manufacturing sites during the technology transfer phase of products
• Review of site data to guarantee all data can be used within the relevant regulatory submissions and filings
• Responsible for QC training of new sites
• Responsible for advanced support within QC and manufacturing to operational PET/ SPECT CMOs. Working closely with GE Healthcare's team of regional field engineers to ensure a high-level of support, particularly within QC and manufacturing
• 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
• Give 'voice of customer' input to R&D group on the commercial manufacturing requirements for new PET tracers in China
• Provide support to customers and to QA for product complaints related to the products at the Chinese CMO
• 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.

Other details
• Driver – Is proactive, makes things happen and can ensure that supporting documentation is in place to support justifications.
• Recognized as a problem solver a source of practical and theoretical knowledge.
Qualifications/Requirements

Qualifications:
• Fluent in English
• Bachelor's degree in chemistry / chemical engineering or similar scientific discipline
At least 3 years' experience working in the pharmaceutical industry (quality control, manufacturing, or technical support)
• Experience in SPECT/PET tracer manufacture and quality control is preferred (cyclotrons, chemistry systems platforms, QC methodology)
• Understanding of the regulatory environment of pharmaceuticals in China

Key skills must include:
• Strong problem-solving abilities for remote and on-site 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 in China is geographically separated from other advanced application team members in the global team. Able to provide scientific and technical leadership across global functions and the business.
About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Primary Country

China
Primary State/Province

Shanghai
Primary City

Shanghai