Lead Analytical Scientist: E&L Risk & Methods

MS0160 GE Healthcare Limited; Oslo fylke; On-site; NOK 1,000,000 - 1,600,000; Full time

Job summary

GE HealthCare is seeking a Lead Analytical Scientist to join the Analytical Chemistry team within CMC Development. You will lead Extractables & Leachables risk assessments across NPI programs, coordinate studies, and ensure data is robust for regulatory submissions.

The ideal candidate has a PhD or MSc in analytical sciences, strong GDP documentation, and experience with LC-MS, GC-MS, and ICP-MS in cross-functional, multinational teams. Fluency in English is required.

Qualifications

• Ph.D. or MSc in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or related field.
• Strong GDP documentation and regulatory writing practices.
• Experience with E&L studies and regulatory submissions is preferred.
• Excellent communication in cross-functional, multicultural teams.

Responsibilities

• Serve as SME for Extractables & Leachables across the CMC development portfolio.
• Lead risk-based E&L assessments, gap analyses, and mitigation planning.
• Coordinate with internal teams and external labs for study execution.
• Prepare and review protocols and regulatory submission documents (INDs, NDAs, MAAs).
• Maintain up-to-date knowledge of regulatory expectations in E&L.

Skills

GDP documentation

Regulatory knowledge

Cross-functional collaboration

Scientific writing

English fluency

Education

PhD or MSc in Analytical Chemistry

Tools

LC-MS

GC-MS

ICP-MS

Job description

GE HealthCare is seeking a Lead Analytical Scientist to join the Analytical Chemistry team within CMC Development. You will lead Extractables & Leachables risk assessments across NPI programs, coordinate studies, and ensure data is robust for regulatory submissions.

The ideal candidate has a PhD or MSc in analytical sciences, strong GDP documentation, and experience with LC-MS, GC-MS, and ICP-MS in cross-functional, multinational teams. Fluency in English is required.