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About the role
- Manage Manufacturing Science and Technology for LAI products at GSK. Oversee technical delivery, risk management, and drive compliance for pharmaceutical production.
Responsibilities
- Manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for a Long-Acting Injectable (LAI) product family.
- 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 stage-gate forums as the program approaches PPQ.
- 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.
Requirements
- Degree in a relevant technical, scientific or engineering discipline (for example pharmacy, chemistry, chemical/biochemical engineering).
- Experience with long-acting injectables, or other relevant aseptic formulations.
- Knowledge/experience in drug product manufacturing, MSAT, process development or technical transfer roles in the pharmaceutical industry.
- Practical knowledge of risk tools (for example FMEA), control strategy development and statistical concepts for CPV.
- Demonstrable experience of technology transfer, process validation or continued process verification.
- Knowledge of good manufacturing practice (GMP) and product lifecycle management principles.
- Experience working in cross-functional teams and managing stakeholder expectations.
Benefits
- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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