Lead Analytical Scientist, E&L Risk & Method Development

GE HealthCare

Chalfont St Giles

On-site

GBP 90,000 - 130,000

Full time

5 days ago

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Job summary

GE HealthCare is seeking a Lead Analytical Scientist to drive Extractables & Leachables assessments across a broad portfolio, including contrast media and radiopharmaceutical development. You will identify knowledge gaps, shape risk‑based strategies, coordinate studies, and interpret data to ensure patient safety and regulatory compliance.

The ideal candidate brings a strong analytical chemistry background with chromatographic and spectroscopic expertise, a track record of GDP-compliant

Qualifications

PhD or MSc in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or related field.
Strong theoretical and practical understanding of method development and validation per ICH and GDP.
Excellent documentation and scientific writing skills with GDP discipline.
Strong communication and collaboration across diverse teams.
Fluent in English, both written and verbal.

Responsibilities

Serve as Analytical Chemistry SME for Extractables & Leachables across CMC.
Lead risk-based E&L assessments for NPI programs; perform gap analyses and mitigation.
Collaborate with cross-functional teams to define E&L objectives and timelines.
Coordinate E&L activities with external labs and partners.
Author and review protocols, reports and regulatory documentation (INDs/NDAs/MAAs).
Maintain awareness of regulatory expectations and industry best practices.