Senior Scientist/Investigator- Cell and Gene Therapy Quality Control
In recent years, GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for Rare Diseases. More recently, this approach has started to show similar transformational potential in the oncology field, and GSK has secured 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 Oncology and other theurapeutic areas 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 ATD team needs to increase capacity to ensure appropriate quality control of the growing portfolio and evaluate / develop and introduce new technologies and systems to advance the analytical strategy ensuring efficient delivery of quality products to the patient.
• Quality control of gene therapy products under development within GSK or at third parties.
• Contribute to design and implementation of fit for purpose analytical methods
• Participate in the investigation or review of change controls, quality deviations and out of specification results
• Compliance with regulations, guidelines and best practice
• Manage analytical data in appropriate systems to ensure compliance and data integrity
• Provide data, and commentary for regulatory submissions
• Support the requirements of the internal vector manufacturing team based in Upper Merion, in addition to any third parties, and the CGT QC team based at Stevenage to ensure that the right systems are in place for the quality control strategy of vector manufacture and release.
• Support the cell processing requirements at third parties to ensure the right systems are in place for the quality control strategy of cell process and release
• Establish ways of working and implement any SOPs / instructions / guidelines required to manage quality control samples, data and documentation transfer / sharing between manufacturing at Upper Merion, QC at Stevenage and any third parties. .
• Contribute to the quality control aspects of product development within GSK and with collaborators and third parties.
• Author and review analytical method, qualification and validation documentation ensuring alignment with GSK standards.
• Oversight of analytical technology transfer both internal and third party
• Collate and analyse analytical data to support process control and product characterisation, release and stability.
• Understanding of the regulatory requirements for cell and gene therapy products and identification of gaps.
• Ensure that any analytical non-conformance or OOS is appropriately investigated and documented, and appropriate change control systems are followed.
• Ensure all work is performed following data integrity principles.
• Establish/maintain/support engagement with external network.
• Support the delivery of relevant sections of regulatory filings.
• Ensure supply, quality and stability of cell banks, reference standards and critical reagents
• Work with CGT Process, Analytical and Quality Control teams to lead on the implementation of the quality control strategy for CGT projects.
• Represent QC in MPD Analytical Workstreams where required.
• Follow the risk management process to identify, escalate and develop mitigation plans for risks
• Challenge ways of working, suggest improvements and lead on the implementation of improvements to business and quality systems
• Support Quality Control during internal audits and regulatory inspections where required.
• Write and review departmental documents subject to internal and regulatory agency review.
• Work with development teams to ensure alignment where possible of analytical equipment and processes to ensure that the lifecycle of an analytical method is understood and appropriately documented to support product filing.
• Escalate any concerns associated with the ongoing ability to test and release or confirm stability of CGT products to QC management or project leaders as appropriate
Excellent communication, presentation skills are required, as well as demonstrable ability to work effectively in multi-disciplinary and multi-cultural teams. This role will support the current US QC Manager for several projects. The role requires external engagement with collaborators and 3rd parties. As such, experience with working with 3rd parties and management of outsourced work is desirable. European and international travel may be required at times, as dictated by the project needs.
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. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.
BSc or equivalent in Biotechnology, Biological Science or related discipline
Experience of Quality Control for Cell and Gene Therapy or Biopharmaceutical products
Qualification and Validation of Analytical methods
Tech Transfer of Analytical Methods
Experience of working to GMP
Strong organisational and communication skills
Demonstrable ability to work in multi-disciplinary, multi-cultural teams
Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives.
Experience of analytical development and quality control for cell therapy products
Experience and understanding of analytical techniques related to characterisation of viral vectors and cell products
Experience of working with third parties
Experience of regulatory interactions and regulatory documentation
Ability to interact successfully with external auditors
Experience of leading matrix teams to deliver project requirements
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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