
Senior Specialist Extractables & Leachables provides expertise and support for Medicines Large Molecules & Vaccines division. Conducts E&L risk assessments, creates and updates internal standards, and benchmarks internally and externally. Represents GSK in external working groups and conferences. Manages risks escalation and provides technical information to support business decisions and regulatory filings. Collaborates with internal and external laboratories to ensure E&L testing is conducted effectively. Participates in MSA process for E&L lab suppliers and interacts with regulatory agencies during audits. Defines the expertise's lifecycle strategy and manages the network of E&L experts.