Principal Manufacturing Scientist

GE HealthCare • Arlington Heights, IL • 2h ago

Job Description Summary

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.

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 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.

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 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.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $149,600.00-$224,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). 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.

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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.

Relocation Assistance Provided: Yes

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