Lead Analytical Scientist – E&L & Method Development

GE HealthCare; Oslo fylke; On-site; NOK 900,000 - 1,300,000; Full time

Job summary

GE HealthCare is seeking a Lead Analytical Scientist to support Extractables & Leachables (E&L) programs within the PDx CMC Development group. You will lead risk-based E&L assessments across NPI projects, coordinate experimental studies, and interpret data to ensure patient safety and regulatory compliance.

The ideal candidate has a strong analytical chemistry background with chromatographic and spectroscopic techniques, plus experience applying risk-based approaches to product and process

Qualifications

• Ph.D. or MSc in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related field.
• Strong theoretical and practical understanding of method development and validation per ICH and regulatory guidelines.
• Excellent documentation and GDP adherence; strong scientific writing.
• Fluent in English, written and spoken; ability to collaborate cross-functionally.

Responsibilities

• Serve as Analytical Chemistry SME for Extractables & Leachables across CMC development portfolio.
• Lead risk-based E&L assessments, gap analyses, and mitigation planning.
• Collaborate with cross-functional CMC teams to define E&L objectives and timelines.
• Coordinate E&L activities with internal labs and external partners.
• Prepare and review protocols, reports, and regulatory submission documents (INDs, NDAs, MAAs).

Skills

Analytical chemistry

Method development

Risk-based assessment

E&L studies

Regulatory knowledge

GDP documentation

Cross-functional teamwork

Scientific writing

English communication

Education

PhD in Analytical Chemistry

MSc in Analytical Chemistry

Tools

LC-MS

GC-MS

ICP-MS

Job description

GE HealthCare is seeking a Lead Analytical Scientist to support Extractables & Leachables (E&L) programs within the PDx CMC Development group. You will lead risk-based E&L assessments across NPI projects, coordinate experimental studies, and interpret data to ensure patient safety and regulatory compliance.

The ideal candidate has a strong analytical chemistry background with chromatographic and spectroscopic techniques, plus experience applying risk-based approaches to product and process