Senior Specialist Extractables & Leachable (18 months contract)

Job description

Job Purpose The job owner has a GSME role in Extractables & Leachables. The job owner acts as primary GSME support for Medicines Large Molecules & Vaccines division including related CMOs. The job owner aligns the E&L GSC strategy with R&D, who are accountable for new product development and commercialization, aiming for a smooth transfer of commercial products. The job owner will conduct and document E&L risk assessments for biopharmaceutical manufacturing processes, container closure systems and dosing device (an interim until LSME network in Medicines Large Molecules division is in place and in use.) The job owner has the task to create and/or update the relevant internal standards (GQP, GQSOP, GG etc.) related to E&L strategy deployed in GSC. The job owner benchmarks internally and externally in the domain of expertise. The job owner will advocate GSK E&L position externally through international working groups (A3P, ISPE, BPOG,…) and/or conferences. The job owner manages risks escalation to the different parts of GSK. This job aims at providing expertise and supporting the GSK network. The job owner must deliver key technical information to business partners, to support busine...