Lead Analytical Scientist, Extractables & 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

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