General Electric PET Advanced Application Specialist in Home/Remote/Alternate, Tennessee
Job Description Summary
This position will be a key member of a global multifunctional team and be responsible for supporting the development and commercialization of clinical phase PET radiopharmaceuticals as well as technology transfers of commercial PET products. Key accountabilities will include setup of new Contract Manufacturing Organizations for production of GMP radiotracers and continual support of these facilities.
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.
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 of CMO operations
Support daily operations of the CMO network
Interface with GEQA on CMO activities
Deployment of product updates and enhancements
Review of site data to ensure accuracy for relevant regulatory submissions and filings
Significant travel may be required within the US and Europe
Bachelor’s degree in chemistry / chemical engineering or similar scientific discipline or least 7 years’ experience working in the pharmaceutical industry (manufacturing, R&D, or technical support)Experience in PET tracer manufacture (cyclotrons, chemistry systems platforms, QC methodology)
Demonstrated ability to lead projects and project teams
Demonstrated ability to identify and implement Best Practices
Ability to deal with high levels of ambiguity
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. Has 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.
Other: Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Maintaining full Quality System Regulation and Current Good Manufacturing Practices requirements
Maintaining full regulatory compliance and other legal requirements
Knowledge and understanding of production process Work Instructions and operates within them to ensure that a device conforms to its specifications
GE Healthcare is an extraordinary place to be for those who embrace challenges and jump on opportunities. We use every moment to do the things that matter, because we’re the people who care about the people who care.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No