Advanced Application Specialist (MSAT Engineer or Scientist)

• 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.