Advanced Application Specialist

Job Description SummaryGE 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.

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 or similar scientific discipline

·         At least 5 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 highly desirable

·         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:

·         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.

 

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.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.