Lead Analytical Scientist - Extractables and Leachables
Core
Lead risk-based Extractables & Leachables (E&L) assessments for contrast media and radiopharmaceutical development to ensure patient safety and regulatory compliance.
Role type
Lead Analytical Scientist (E&L)
Builds
Regulatory documentation and risk mitigation strategies for NPI programs
Domain
Pharmaceutical Diagnostics / Medical Technology
Deliverable
client delivery
Required skills
Extractables & Leachables assessment, risk-based strategies, method development and validation, regulatory guidelines (ICH, USP <1663-1665>), LC-MS, GC-MS, ICP-MS, technical writing, cross-functional collaboration
Preferred skills
NDA/MAA submission experience, standardized work practices development, Norwegian language
Technologies
LC-MS, GC-MS, ICP-MS
Responsibilities
Lead risk-based E&L assessments including gap analyses and mitigation planning; Author and review scientific protocols and reports for regulatory submissions; Coordinate E&L activities with internal teams and external laboratories; Maintain knowledge of regulatory expectations and industry best practices.
Seniority
Lead, hands-on IC
