Advanced Application Specialist

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Requirements:

• Bachelor’s degree in chemistry / chemical engineering or similar scientific discipline
• At least 5 years’ experience working in the pharmaceutical industry (manufacturing, R&D, or technical support)
• Experience in PET tracer manufacture (cyclotrons, chemistry systems platforms, QC methodology) is highly desirable
• Demonstrated ability to lead programs and develop teams.
• Demonstrated ability to identify and implement Best Practices and deal with high levels of ambiguity
• Demonstrated ability to work cross-functionally and fulfill company priorities

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.
• 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