Job Description Summary

GE HealthCare’s PET Supply Chain-Americas 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.

Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance.

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.

Job Description

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

 

Qualifications:

• Bachelor’s degree in Chemistry, Chemical Engineering, Radiochemistry, or a closely related scientific discipline.

• Minimum 5 years of hands-on experience in the pharmaceutical or radiopharmaceutical industry, with a focus on GMP manufacturing, R&D, or technical operations.

• Knowledge of PET tracer production, including cyclotron operation, automated synthesis platforms, and analytical/QC methodologies (e.g., HPLC, GC, TLC, dose calibrators) is highly desired.

• Proven track record of leading complex technical programs, including process development, scale-up, and technology transfer.

• Demonstrated ability to mentor and develop technical teams, fostering innovation and continuous improvement.

• Strong problem-solving skills with the ability to navigate ambiguity and implement best practices in highly regulated environments.

• Experience working cross-functionally with QA, Regulatory Affairs, Supply Chain, and external partners to meet business and compliance objectives.

 

Preferred Qualifications:

• Master’s degree (MS or equivalent) in Chemistry, Radiochemistry, or Life Sciences, with 10+ years of experience in pharmaceutical or radiopharmaceutical development.

• At least 5 years of direct experience in GMP radiopharmaceutical manufacturing, including validation, documentation, and regulatory inspections.

• Deep understanding of regulatory frameworks and experience supporting product quality, compliance, and supply continuity.

• Experience with tech transfer from R&D to commercial manufacturing, including authoring and