Senior Scientist, Cell and Gene Therapy, Analytical
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jul 13 2021 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 endeavor 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 and qualification of analytical method and transfer to internal Product Development and QC laboratories, and CMOs or testing laboratories Perform analytical testing to support process development Support laboratory and equipment maintenance Support external collaborations to enhance our analytical capabilities and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products Partcipate in risk assessments to develop robust product control strategies for cell/gene therapy programs Executes and write up scientific experiments in a timely manner and with high quality Support training of colleagues in QC and Product Development Interact with third parties and testing laboratories. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS and 3 years hands-on experience in analytical method development for large molecules in biology, cell biology, virology, biochemistry, analytical chemistry, or MS 1 year hands-on experience in analytical method development for large molecules in biology, cell biology, virology, biochemistry, analytical chemistry 2 years experience in molecular biology techniques 1 year experience in technical writing skills 1 year experience working in multi-disciplinary, multi-cultural teams Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in analytical development in support of recombinant viral vector production and T-cell therapies Experience in the development of cell-based and molecular biological analytical methods to characterise viruses and cells such as flow cytometry, clonogenic potential assays, imaging, qPCR and ddPCR Experience of vaccines, biopharmaceutical or cell and gene therapy product development Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis Experience of investigations into out of specification, out of trend or process deviations including root cause analysis, impact assessment and development of appropriate corrective and preventative actions Experience generating regulatory documentation Experience in analytical method transfers, qualification and control strategy development Strong organisational and excellent interpersonal communication skills Why GSK? 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. 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