Job Description Summary

Job Description

Key Responsibilities

• Act as technical manufacturing product owner for assigned PET products ensuring robust compliant processes across development validation and LCM.

• Serve as an SME in radiochemistry and radiopharmaceutical manufacturing providing expert input for deviations investigations change controls and process improvements.

• Perform handson manufacturing and technical work including troubleshooting / problem solving experimental work engineering runs and validation activities.

• Lead and execute engineering batches and process validation ensuring process capability and regulatory alignment.

• Author review and maintain GMP documentation including SOPs manuals troubleshooting guides risk assessments validation documentation protocols and technical reports.

• Analyze batch and process data to identify trends share learnings across the network and drive continuous improvement and reliability.

• Contribute as a member of latestage development and CMC teams supporting regulatory submissions and health authority interactions.

• Provide technical leadership and project support for technology transfers to internal and external manufacturing partners.

• Act as the voice of manufacturing for NPI and LCM projects translating commercial manufacturing requirements into R&D and process design inputs.

• Build LCM frameworks and promote standardization across the global.

Qualifications & Experience

• Bachelors degree in Radiochemistry Chemistry Pharmaceutical Sciences or a related discipline.

• Minimum 5 years of experience in PET or radiopharmaceutical manufacturing within a GMP environment.

• Demonstrated experience with FastLab or automated PET synthesis platforms.

• Working knowledge of CMC requirements including manufacturing sections of IMPD NDA or MAA dossiers.

• Practical experience in radiopharmaceutical manufacturing.

Desired Skills & Characteristics

• Masters Degree or PhD in Radiochemistry Chemistry Pharmaceutical Sciences or a related discipline.

• Strong problemsolving and rootcause analysis skills including remote troubleshooting support.

• Strong technical writing skills for clear compliant GMP documentation.

• Datadriven mindset with strong data analysis and statistical skills.

• Ability to work independently and with high autonomy in a global matrixed organization.

• Strong communication and influencing skills in English (Dutch preferred).

• Customerfocused approach with the ability to build effective relationships with global manufacturing partners and stakeholders.

• Ability to travel to other manufacturing sites for problem solving and project support.

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.