Lead Analytical Scientist, E&L & NPI Risk Strategy

GE HealthCare; Oslo fylke; Sur place; NOK 1 000 000 - 1 400 000; Plein temps

Résumé du poste

GE HealthCare is seeking a Lead Analytical Scientist in Oslo to drive Extractables & Leachables programs across the CMC development portfolio. You will lead risk-based assessments, coordinate internal and external activities, and ensure regulatory compliance through rigorous data interpretation and documentation.

The role requires a PhD or MSc in a related field, expertise in method development/validation per ICH guidelines, and strong written and spoken English.

Qualifications

• Ph.D. or MSc in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or a related field.
• Strong theoretical and practical understanding of method development and validation per ICH/regulatory guidelines.
• Excellent documentation and technical writing skills with GDP adherence.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Motivated, rigorous, detail-oriented, and committed to continuous improvement.
• Strong analytical thinking and problem-solving skills.
• Fluent in English, both written and verbal.

Responsabilités

• Serve as the Analytical Chemistry subject matter expert for Extractables & Leachables across the CMC development portfolio
• Lead risk-based E&L assessments across NPI programs, including risk evaluations, gap analyses, and mitigation planning.
• Collaborate with cross-functional CMC project teams to define and deliver E&L-related objectives and timelines.
• Coordinate and manage E&L activities internally and with external laboratories and development partners.
• Author and review scientific protocols, reports and documentation supporting regulatory submissions including INDs, IMPDs, NDAs, and MAAs.
• Maintain current knowledge of regulatory expectations and industry best practices related to E&L.
• Contribute to the development and continuous improvement of E&L strategies, and develop efficient, standardized work practices.

Connaissances

Analytical thinking

Problem-solving

Communication

Cross-functional collaboration

Scientific writing

Formation

Ph.D. or MSc in Analytical Chemistry / related field

Outils

LC-MS

GC-MS

ICP-MS

Description du poste

GE HealthCare is seeking a Lead Analytical Scientist in Oslo to drive Extractables & Leachables programs across the CMC development portfolio. You will lead risk-based assessments, coordinate internal and external activities, and ensure regulatory compliance through rigorous data interpretation and documentation.

The role requires a PhD or MSc in a related field, expertise in method development/validation per ICH guidelines, and strong written and spoken English.