The incumbent will have a Bachelor's degree or equivalent in an appropriate scientific discipline plus experience in authoring of regulatory documentation, product development-commercial manufacturing interface and expertise in continuous improvement and change management.
Having a Masters or equivalent in an appropriate scientific discipline with significant drug product formulation experience would be an added benefit.
In this role you will provide overall leadership for and direction of formulation science carried out externally at CRO/CMO's. In scope your work will include developability, formulation development, and clinical trial supply manufacture across all phases of clinical development. You will provide technical expertise and CRO/CMO oversight at all stages of product development. You will ensure CRO/CMO's develop phase appropriate, robust formulations suitable for clinical evaluation. As the incumbent you will manage the development and supply elements associated with external CRO/CMO activities. You will also progress externally manufactured Drug Product through the internal GSK receipt and release process.
• Ensure that Drug Product is formulated and supplied to meet the agreed needs of the Project Team.
• Engage with GSK project teams to identify and understand project requirements and timeframes.
• Provide the GEDS interface with the wider Project Team.
• Coordinate the activities of the external team and raise issues as necessary with project teams
• Engage and assess supplier proposals against project requirements and make sourcing recommendations with Procurement/NCGOM
• Ensure safety, quality and ethical standards are appropriately maintained in CRO/CMO operations.
• Ensure generation and storage of appropriate documentation (including contribute to regulatory submissions in support of clinical studies where required).
• Have a project plan and an assessment of risks that are reviewed and endorsed by the relevant lines.
• Make appropriate and accurate budget provision to deliver the agreed project plan.
• Use current R&D project governance processes for communication and review of project progress and issues.
• Be responsible for contributions from own line to regulatory submissions and ensure coordination with the contributions from other GEDS/PDS lines.
• Comply with applicable quality and regulatory requirements in all aspects of work.
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