Lead Analytical Scientist, Extractables & Leachables

GE HEALTHCARE AS; Oslo fylke; Sur place; NOK 1 100 000 - 1 400 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Comprehensive benefits

Career opportunities in a global med‑t

Résumé du poste

GE HealthCare’s Analytical Chemistry team within the CMC Development organization leads Extractables & Leachables (E&L) assessments for early-phase programs and NPI projects. The Lead Analytical Scientist will drive risk-based strategies, coordinate studies, and interpret data to ensure patient safety and regulatory compliance.

The role requires a strong background in analytical chemistry, chromatography, spectroscopy, and experience applying risk-based approaches to development.

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 other regulatory guidelines.
• Excellent documentation and GDP adherence.
• Fluent in English, both written and verbal.
• Experience with E&L studies and LC-MS/GC-MS/ICP-MS.
• Experience with regulatory submissions (INDs, NDA, MAA).
• Motivated, scientifically rigorous, detail-oriented and collaborative.

Responsabilités

• 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.
• Coordinate with cross-functional CMC teams to achieve E&L objectives and timelines.
• Coordinate and manage E&L activities with external laboratories and partners.
• Prepare and review protocols and reports for regulatory submissions (INDs, NDAs, MAAs).
• Maintain current knowledge of regulatory expectations and industry best practices.
• Contribute to development and continuous improvement of E&L strategies.

Connaissances

Technical writing

Communication

Analytical thinking

Problem solving

English fluency

Formation

Ph.D. or M.Sc. in Analytical Chemistry/Pharmaceutical Sciences/related field

Outils

LC-MS

GC-MS

ICP-MS

Description du poste

GE HealthCare’s Analytical Chemistry team within the CMC Development organization leads Extractables & Leachables (E&L) assessments for early-phase programs and NPI projects. The Lead Analytical Scientist will drive risk-based strategies, coordinate studies, and interpret data to ensure patient safety and regulatory compliance.

The role requires a strong background in analytical chemistry, chromatography, spectroscopy, and experience applying risk-based approaches to development.