Principal Manufacturing Scientist

GE HEALTHCARE • Arlington Heights, IL

7d

About The Position

The Principal Manufacturing Scientist is a Subject Matter Expert (SME) in radiopharmaceutical manufacturing and radiochemistry. The role acts as global technical product owner for PET radiopharmaceuticals manufactured on the FastLab platform, with end‑to-end accountability from late‑stage development through validation and lifecycle management (LCM).

The position combines hands‑on technical work with scientific leadership, CMC contribution, and GMP documentation ownership, supporting commercialization, sustained supply, and continuous improvement across GE HealthCare’s global PET manufacturing network and the AH SPECT facility.

Requirements

• 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.

Nice To Haves

• Masters Degree or PhD in Radiochemistry, Chemistry, Pharmaceutical Sciences, or a related discipline.
• Strong problem‑solving and root‑cause analysis skills, including remote troubleshooting support.
• Strong technical writing skills for clear, compliant GMP documentation.
• Data‑driven 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).
• Customer‑focused 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.

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 hands‑on 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 late‑stage 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.

Benefits

• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees