GE HealthCare PET Advanced Application Specialist 

Mexico, Mexico City 

327890661

Responsibilities:

• 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
• Travel may be required within North and South America (up to 15%)

Qualifications:

• Bachelor’s degree in chemistry / chemical engineering or similar scientific discipline OR equivalent work experience
• 5 years of experience working in the pharmaceutical industry (manufacturing, R&D, or technical support).
• Demonstrated ability to lead programs and develop teams.
• Demonstrated ability to identify and implement Best Practices and deal with high levels of ambiguity.
• Demonstrated ability to work cross-functionally and fulfill company priorities.

Preferred Qualifications:

• Experience in PET tracer manufacture (cyclotrons, chemistry systems platforms, QC methodology) is highly desirable.
• MS in Chemistry or Life Sciences with at least 10 years’ experience in a pharmaceutical environment and at least 5 years’ experience in GMP radiopharmaceutical manufacturing and/or development.
• 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.

Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Application Deadline: May 30, 2025