GE HealthCare Advanced Application Specialist 

Remote, Remote 

476626541

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.

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.

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 or similar scientific discipline

At least 5 years’ experience working in the pharmaceutical industry (manufacturing, R&D, or technical support)

Demonstrated ability to identify and implement Best Practices and deal with high levels of ambiguity

Preferred Qualifications:

MS 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.

synthesis within.

Application Deadline: April 21, 2025