The job owner acts as primary GSME support for the Medicines Large Molecules & Vaccines division, aligning E&L GSC strategy with R&D for smooth commercial product transfer
Job Summary
The job owner acts as primary GSME support for the Medicines Large Molecules & Vaccines division, aligning E&L GSC strategy with R&D for smooth commercial product transfer.
Responsibilities include conducting and documenting E&L risk assessments, creating/updating internal standards, benchmarking, and advocating GSK's E&L position externally.
This role involves working with internal and external laboratories, participating in supplier technical agreements and audits, and interacting with regulatory agencies.
Matching Summary
The job owner acts as primary GSME support for the 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, GG)
External benchmarking
Regulatory filings support
Nice-to-have
Interpersonal and communication skills
Effective matrix organization work
Teamwork and networking ability
Coaching and mentoring skills
Problem-solving attitude
Customer focus
Proposing solutions in critical situations
Key Requirements
4+ years of experience in E&L, Validation, or Risk Management