Lead Radiochemist

Job Description Summary

As a Lead Radiochemist in the Pharmaceutical Diagnostics (PDx) R&D Radiochemistry team, you will play a pivotal role in identifying and developing novel radiopharmaceuticals within a multidisciplinary Chemistry, Manufacturing and Controls (CMC) development team. You will provide technical leadership in developing robust radiopharmaceutical manufacturing methods suitable for clinical translation, registration and commercialisation. Key business areas are neurology, oncology and cardiology, where GE HealthCare provides radiopharmaceuticals across the PET and SPECT imaging modalities.

Job Description

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE HealthCare Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Essential Responsibilities

• Leading the development of robust radiolabelling methods and manufacturing processes for the reliable supply of radiopharmaceuticals, from pre-clinical and clinical translation through commercial production and into life-cycle management.
• Providing technical leadership for radiochemistry workstreams within multidisciplinary CMC program teams, with accountability for the quality and timely delivery of radiochemistry deliverables.
• Designing and performing radiochemistry laboratory experiments and directing and collaborating remotely with scientists at partner sites, CROs and CDMOs who perform experimental work.
• Applying Quality by Design (QbD) principles and risk-assessment tools (e.g., FMEA) to process development, and contributing to specification setting, process validation and stability program.
• Developing and optimizing automated synthesis processes on commercial radiosynthesis platforms (e.g., FASTlab).
• Leading technology transfer of radiolabelling processes to external CMOs and CDMOs and academic partners, including preparation of transfer protocols, training and troubleshooting.
• Authoring and reviewing laboratory records, development reports and research publications, and contributing CMC content to regulatory submissions (e.g. IND, IMPD, NDA, MAA).
• Representing radiochemistry in cross-functional and governance forums and influencing technical decisions across the business.
• Ensuring all work complies with radiation protection requirements (ALARA), Good Documentation Practice (GDP) and data-integrity principles.

Basic Qualifications/Requirements

• PhD or MSc in Radiochemistry, Chemistry or a related field or equivalent knowledge and experience.
• Hands-on experience in radiolabelling with one or more radionuclides (e.g., [68Ga]gallium, [18F]fluoride, [64Cu]copper, [99mTc]technetium) for small and large molecules using direct or synthon-based methods, and strong scientific knowledge of the established chemistries used in diagnostic radiopharmaceutical products.
• Experience in CMC development of radiopharmaceuticals, including automation of manufacturing processes.
• Experience with academic and/or commercial radiopharmaceutical product development or production.
• Excellent written and verbal communication skills in English, including technical writing for regulatory submissions and presenting to senior stakeholders.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Inclusion & Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law.
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