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
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
Bachelor’s degree in chemistry / chemical engineering / process engineering or similar scientific discipline
At least 5 years’ experience working in the radiopharmaceutical, pharmaceutical or biotech industry (manufacturing, MSAT, R&D, or technical support)
Demonstrated experience working on tech transfers, technical troubleshooting, scale-up and / or MSAT workflows
Demonstrated ability to work cross-functionally with Quality, Engineering, Development, CMC and Manufacturing Operations to fulfill company priorities
Demonstrated ability to work through complex technical challenges with a high degree of accuracy and communication
Demonstrated ability to identify and implement best practices, continuous improvement initiatives, and maintain a data driven approach in a dynamic environment
Master’s degree in Chemistry, Chemical Engineering or Life Sciences with at least 10 years’ experience in a pharmaceutical environment and at least 5 years’ experience working in a GMP environment.
Experience working on transitions from clinical to commercial manufacturing, process, method and equipment validation, and familiarity with applicable regulatory standards is highly desirable.
Experience in PET tracer manufacture (cyclotrons, chemistry systems platforms, QC methodology) is highly desirable
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.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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 HealthCare 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).
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.
Relocation Assistance Provided: No
Top Skills
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence.
As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform.
With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.
We embrace a culture of respect, transparency, integrity and diversity.
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