Position Summary
You will manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for drug product manufacturing of a defined product or product family with a primary focus on New Product Introduction (NPI) and successful product launches, including delivering successful right-first-time product qualifications. You will work with cross-functional teams across functions to ensure robust product control strategies are implemented at manufacturing sites. We value clear problem solving, practical scientific judgement, and collaborative leadership. This role offers growth, meaningful impact and the chance to help GSK unite science, technology and talent to get ahead of disease together.
Responsibilities
- Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision-making and product knowledge.
- Lead and deliver technology transfers to internal sites and external manufacturers, including transfer packages, training and readiness reviews.
- Manage continued process verification,
process performance qualification and change management to maintain product robustness and compliance.
- Drive right-first-time execution of product qualification activities (e.g., PPQ/qualification readiness), managing appropriate governance through the relevant stage-gate forums as the program approaches PPQ, ensuring robust data, clear acceptance criteria and effective issue resolution.
- Define and maintain product control strategy and technical risk assessments. Translate that knowledge into clear documentation for operations.
- Support regulatory submissions and post approval inspections by providing technical input, comparability strategies and supporting documentation.
- Manage cross-functional investigations, root cause analysis and corrective actions for complex deviations and quality events.
Basic Qualification
- Bachelor’s degree in a relevant scientific, engineering or technical discipline.
- Minimum 10
📌 MSAT Drug Product Lead (Burgos)
🏢 GSK
📍 Burgos