Advanced Application Specialist (MSAT Engineer or Scientist)

GE HEALTHCARE • OH

81d

About The Position

GE HealthCare’s Manufacturing Science and Technology team is searching for an 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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Great work environment.
• Professional development.
• Challenging careers.
• Competitive compensation.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees