GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines a talented workforce and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for Rare Diseases. We now have one approved and two late phase products. More recently, this approach has started to show similar transformational potential in the oncology field, and GSK has a significant collaboration in this area. The progression of our own portfolio together with the promise of newer gene therapy technologies creates an imperative for GSK to build an industry leading gene therapy platform. This will enable delivery of the portfolio in Rare Diseases and Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies.
The CMC capabilities to develop and deliver these products are being built within the Cell and Gene Therapy Platform. As part of the expansion of this platform, the Cell and Gene therapy Quality control team needs to increase capacity to support delivery of quality products to the patient.
• Contribute to the quality control aspects of product development within GSK and with collaborators and third parties.
• Work with Quality control and Validation team to validate equipment and IT systems.
• Author / Review analytical method, Equipment and laboratory systems ensuring alignment with GSK standards.
• Support a technology transfer team to ensure successful transfer and ongoing performance of analytical methods.
• Collate and analyse analytical data to support process control and product characterization, release and stability.
• Understanding of the regulatory requirements for cell and gene therapy products.
• Ensure that any analytical non-conformance or OOS are highlighted to management and investigated.
• Ensure data integrity is maintained for all work performed.
• Contribute in delivery of relevant sections of regulatory filings and responses to regulatory questions.
• Quality control of gene therapy products within GSK or at third parties.
• Ensure analytical methods are fit for purpose through method qualification and validation activities.
• Participate in equipment and IT systems validation activities.
• Participate in the investigation or review of change controls, quality deviations and out of specification results
• Compliance with regulations, guidelines and best practice
• Manage data in appropriate systems to ensure compliance and data integrity
• Provide data for regulatory submissions.
The role will be based in the UK with the Cell and Gene Therapy Product Development and Supply group at Stevenage. European and international travel will be required at times, as dictated by the project needs.
If requiring an adjustment for a disability, once selected for interview you may contact
Closing date: 13th June 2017
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies required for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
If you are a GSK employee, please indicate within your cover letter if you are confirmed as displaced (or potentially displaced) and at risk of redundancy.
You may apply for this position online by selecting the Apply now button.
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