- Permanent, Full Time
- Closes 22nd June 2018
- Requisition ID: WD167615
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for 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’s Cell & Gene Therapy Platform CMC team is being expanded to support an increasing portfolio of cell and gene therapies. The team is responsible for delivering the Chemistry, Manufacturing and Controls (CMC) aspects of the projects from early phase to launch and the development of innovative technologies to enable step-change improvements to cell & gene therapy manufacture.
GSK has a significant collaboration in the T cell immunotherapy field with Adaptimmune and other licensing/partnership opportunities are being pursued. The progression of our own portfolio together with the maturation of emerging gene therapy technologies creates an imperative for GSK to now increase our investment in this space and establish an end to end leading platform. This will facilitate delivery of the portfolio in Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies in other therapeutic areas.
A key CMC challenge in this endeavour is the development of suitable analytical methods that can support both process development and manufacturing of cell and gene therapy products. The successful candidate will join an analytical development group that is currently expanding in the UK and USA and will have the following responsibilities:
• Development of cell- and molecular- based analytical methods and transfer to internal Product Development and QC laboratories, and CMOs or testing laboratories
• Support external collaborations to enhance our analytical capabilities, innovate and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products
• Contribute to product specification development
• Participate in risk assessments to develop robust product control strategies for cell/gene therapy programs
• Responsible for management and successful closure of investigations
• Own and manage analytical method lifecycle during product development, including risk assessments and preparation of qualification reports.
• Support colleagues in QC and Validation and Life Cycle Management for post approval analytical life cycle management
• Responsible for delivery of relevant sections of regulatory filings and responses to regulatory questions
• Support capability build in other functional areas as needed
• Responsible for successful interactions with contract manufacturing at third party manufacturers and testing laboratories. The role requires significant external engagement with 3rd parties (contractors, suppliers, testing laboratories, academic and industry groups).
European and international travel will 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.
Closing date: 22nd June 2018
MSc in immunology, cell biology or related scientific discipline
Strong hands-on experience in the development of immunology assays such as in vitro killing, phenotyping and cytokine measurement.
Expertise in flow cytometry experiment set up and analysis
Strong verbal and written skills
Well organised with multi-tasking skills and the ability to prioritise work supporting multiple programs
Demonstrable ability to work independently and in multi-disciplinary, multi-cultural teams
PhD in related scientific discipline and relevant experience
Experience in the development of cell- and molecular biology-based analytical methods to characterise viruses and cells.
Experience in analytical method transfers internally and externally
Good understanding of diverse cell imaging and analysis techniques, such as multi-colour flow cytometry and immuno-phenotyping
Confident in applying statistics to data as well as troubleshooting of out of specification/trend results Experience working with 3rd parties and developing/maintaining working relationships with these partners
Previous experience with Cell and Gene Therapy or engineered T cells is a plus
Previous experience with Quality by design (QbD) approaches, Design of Experiment (DOE), risk assessments and preparing regulatory documentation is a plus.
Familiarity with generating regulatory documentation
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.
You may apply for this position online by selecting the Apply now button.
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