Site Name: UK - County Durham - Barnard Castle, GSK House, UK - Angus - Montrose, UK - Cumbria - Ulverston, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, UK - North Ayrshire - Irvine, UK - West Sussex - Worthing
Posted Date: Apr 24 2023
This position will be offered as a Fixed Term Contract.
GSK produce one of the worlds leading HIV treatments, it has been developed and industrialised for supply from Barnard Castle. The product lifecycle strategy will require new formulations to be developed and transfer of the product to Parma to support Product Growth, Technology is now available to simplify and accelerate the transfer and industrialization of new product lines. The role will ensure that new technology is applied to this particular HIV treatments.
In this role you will…
- Working with the drug product and device Workstreams, ensure that product and process data are defined that will need to reviewed during product development, industrialization and onward site transfer. Work with Tech and Engineering to ensure defined data are available electronically with batch context, aligning to GSK standards.
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Ensure the product portfolio aligns with GSK enterprise recipe management standards for data and manufacturing and testing methods. Build capability in supply sites to ensure that data and receipes are standardised and enable fast deployment of changes and improvements
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Own the Product Data Lifecycle Management Tool to capture product development history of the new device (syringe / cartridge), working closely with the device team across both R&D and GSC. Development capabilities in MSAT to ensure ongoing ownership and sustainability.
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Working with Tech and MSAT Develop a product and process Control Tower for Cabotegravir, working closely with Tech to ensure that all product and process data, together with genealogy are captured. Build capability within the MSAT team to use the Control Tower for problem solving and identify opportunities for improvement. This will be across the product portfolio.
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Understand where models have been developed to support process understanding. Transfer models as product is scaled up and /or transferred and ensure model is fully embedded and sustainable in GSC.
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Understand GSC sources of data that will be included in regulatory filings. Working with Tech and Engineering functions, ensure that data is available electronically and can be filed automatically eliminating manual data collection and transcription.
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Ensure that on product launch, CPV can be performed automatically, with automated CPV alerts.
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Support the development of a digital knowledge management file for Cabotegravir that is embedded in MSAT and site processes
Our Global Supply Chain (GSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe. The GSC organisation is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product’s quality.
Why you?
Qualifications & Skills:
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BSc in Scientific Discipline
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Demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of Product Lifecycle, including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QBD and Change Control
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Demonstrated ability to drive improvements in a business process, delivering and embedding a business change to ensure sustainable.
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Experience in use of data to drive business improvements.
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An early adopter of new Tech capability, that has been used to deliver business benefit.
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A competent project manager, that can demonstrate experience in scoping and leading complex projects.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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