The Manufacturing Scientist will be responsible for manufacturing of clinical supplies including planning, forecasting and coordinating manufacture of clinical supplies to meet agreed project timelines. The role is also responsible for assisting in the development efforts required bringing the clinical supplies (product) through all phases and then to full scale production at the GSK commercial sites or at external contractor sites.
Represent Clinical Manufacturing on Supply Chain Network Delivery Teams, coordinate with project teams to understand the drug product manufacturing process and provide technical expertise to introduce the process into to the Sterile Manufacturing pilot plant in a compliant manner.
Strong understanding and application of aseptic manufacturing principles to implement new technologies / process to the Sterile pilot plant.
Support the daily activities of the area supporting the manufacture of quality parenteral products to support development and clinical needs.
Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.
Ensure that manufacturing processes remain compliant with all regulatory expectations and GSK policies and standards.
Provide technical expertise in the sterile manufacturing environment, participate in audits of external manufacturing sites as needed.
Oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.
Prepare and review master batch records, process documentation, and bulk production records as needed.
Inspect work area for safety regulations and recommend improvements.
Support external due diligence efforts and technical support for manufacturing at CMO sites as needed.
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Degree or equivalent in a scientific field
5 years of experience in the manufacture of sterile drug products
If you have the following characteristics, it would be a plus:
Experience in pharmaceutical pilot plant technical operations
Experience supporting investigations and deviations
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
Managing individual performance.
Creating a performance culture and driving results, prioritisation, execution, delivering performance.
Setting strategic direction and leading on-going organisational transformation.
Building a resilient organisation.
Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
Managing P&L and capital allocation.
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