Advanced Application Specialist
Job Description Summary
GE HealthCare’s Manufacturing Science and Technology team is searching for an Advanced Application Specialist (Radiochemist). This position’s primary responsibilities will organize and facilitate the technology transfer of GE HealthCare’s licensed radiopharmaceuticals to our selected Contract Manufacturing Organizations (CMO) and provide technical support for commercial manufacturing operations. 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, improve, review and approve 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.
Collaborate with R&D and other key internal stakeholders to ensure technical knowledge is effectively translated to manufacturing operations and supply chain.
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
Required Qualifications:
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, and radiochemistry/radiopharmaceutical science.
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
Preferred Qualifications:
Master’s degree or greater in Chemistry, Chemical Engineering or Radiochemistry 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) or other Radiochemistry/Radiopharmaceutical projects.
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
Relocation Assistance Provided: No
GE HealthCare’s Manufacturing Science and Technology team is searching for an Advanced Application Specialist (Radiochemist). This position’s primary responsibilities will organize and facilitate the technology transfer of GE HealthCare’s licensed radiopharmaceuticals to our selected Contract Manufacturing Organizations (CMO) and provide technical support for commercial manufacturing operations. 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, improve, review and approve 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.
Collaborate with R&D and other key internal stakeholders to ensure technical knowledge is effectively translated to manufacturing operations and supply chain.
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
Required Qualifications:
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, and radiochemistry/radiopharmaceutical science.
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
Preferred Qualifications:
Master’s degree or greater in Chemistry, Chemical Engineering or Radiochemistry 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) or other Radiochemistry/Radiopharmaceutical projects.
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
Relocation Assistance Provided: No