Lead Analytical Scientist - Extractables and Leachables

Ge Healthcare; Chalfont St Giles; On-site; GBP 85,000 - 130,000; Full time

Job summary

GE HealthCare is seeking a Lead Analytical Scientist to support E&L assessment activities across the radiopharmaceutical and contrast media portfolio. You will act as the subject matter expert for Extractables & Leachables within the CMC Development organization, driving risk-based assessments and collaborating with cross-functional teams.

You will author and review protocols and reports for regulatory submissions (INDs, IMPDs, NDAs, MAAs) while staying aligned with GDP and regulatory

Qualifications

• Ph.D. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or a related field.
• Strong theoretical and practical understanding of method development and validation per ICH and regulatory guidelines.
• Excellent GDP-compliant documentation and technical writing skills.

Responsibilities

• Serve as the Analytical Chemistry SME for Extractables & Leachables across the CMC development portfolio.
• Lead risk-based E&L assessments across NPI programs, including risk evaluations and mitigation planning.

Skills

Analytical chemistry

Documentation

Communication

Team collaboration

Problem solving

English fluency

Education

Ph.D. in Analytical Chemistry

M.Sc. in Analytical Chemistry

Tools

LC-MS

GC-MS

ICP-MS

Job description

The Analytical Chemistry team is part of the Chemistry, Manufacturing and Controls (CMC) Development organization within Pharmaceutical Diagnostics (PDx) at GE HealthCare. The team provides analytical characterization, method development, and technical documentation support for early-phase research programs and New Product Introduction (NPI) projects., We are seeking a highly motivated and innovative Lead Analytical Scientist to join our team to support our growing portfolio of Extractables & Leachables (E&L) assessment activities. In this role, you will work across cross-functional project teams to assess E&L risks throughout our contrast media and radiopharmaceutical development portfolio. You will identify knowledge gaps, develop risk-based strategies, coordinate experimental studies, and interpret data to ensure patient safety and regulatory compliance.,

• Serve as the Analytical Chemistry subject matter expert for Extractables & Leachables across the CMC development portfolio
• Lead risk-based E&L assessments across NPI programs, including risk evaluations, gap analyses, and mitigation planning.
• Collaborate with cross-functional CMC project teams to define and deliver E&L-related objectives and timelines.
• Coordinate and manage E&L activities internally and with external laboratories and development partners.
• Author and review scientific protocols, reports and documentation supporting regulatory submissions including INDs, IMPDs, NDAs, and MAAs.
• Maintain current knowledge of regulatory expectations and industry best practices related to E&L.
• Contribute to the development and continuous improvement of E&L strategies, and develop efficient, standardized work practices.
• The ideal candidate will have a strong background in analytical chemistry, including chromatographic and spectroscopic techniques, along with experience applying risk-based approaches to product and process development.
• Ph.D. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or a related field.
• Strong theoretical and practical understanding of method development and validation in accordance with ICH and other relevant regulatory guidelines.
• Excellent documentation and technical writing skills, with strong adherence to Good Documentation Practices (GDP).
• Strong communication and interpersonal skills, with the ability to collaborate effectively in cross-functional and multicultural environments.
• Highly motivated, scientifically rigorous, detail-orientated and committed to continuous improvement.
• Strong analytical thinking and problem-solving skills.
• Fluent in English, both written and verbal.
• Experience supporting Extractables & Leachables studies.
• Familiarity with risk-based assessment approaches and regulatory expectations.
• Experience supporting NDA, MAA, or other CMC regulatory submissions.
• Experience with LC-MS, GC-MS, ICP-MS, and other analytical techniques commonly used for E&L characterization.
• Familiarity with USP <1663>, USP <1664>, USP <1665>, PQRI recommendations, and related industry guidance.
• Fluency in Norwegian, or willingness to learn if based in Oslo.
• GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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 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 expression, age, disability, protected veteran status, or other characteristics protected by law. We expect all employees to live and breathe our behaviors: act with humility and build trust; lead with transparency; deliver with focus; and drive ownership - always with unyielding integrity. 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.