Act as primary GSME support for Medicines Large Molecules & Vaccines division, aligning E&L GSC strategy with R&D for smooth commercial product transfer
Job Summary
Act as primary GSME support for Medicines Large Molecules & Vaccines division, aligning E&L GSC strategy with R&D for smooth commercial product transfer.
Conduct and document E&L risk assessments, create/update internal standards, benchmark expertise, and advocate GSK's E&L position externally.
Provide expertise support, manage risks escalation, deliver technical information for business decisions and regulatory filings, and interact with laboratories and regulatory agencies.
Matching Summary
Act as primary GSME support for Medicines Large Molecules & Vaccines division, aligning E&L GSC strategy with R&D for smooth commercial product transfer.
Skills & Requirements
Must-have
Extractables & Leachables expertise
Biopharmaceutical manufacturing processes
Container closure systems
Dosing device assessment
Internal standards development (GQP, GQSOP)
External representation (A3P, ISPE, BPOG)
Nice-to-have
Strong interpersonal and communication skills
Ability to work in a matrix organization
Teamwork ability
Networking and facilitation skills
Problem solving attitude
Customer focus
Key Requirements
4+ years of experience in E&L, Validation, or Risk Management