Sr. Scientist, Downstream Process Development Analytical
- PhD or equivalent experience in Biological Sciences.
- Experience of running cell based and biochemical assays to deliver decision making data for process development projects.
- An interest in and willingness to develop skills in downstream process development of viral vector bioprocessing and scale up (up to 200L).
- Experience in running cell based assays to deliver critical data for project teams, with FACS and qPCR readouts, ideally that would include titration of viral samples to determine functional titres.
- Experience of running biochemical assays to deliver critical data for project teams, especially ELISA assays and ideally the determination of physical titre and infectivity for viral vector samples.
- Experience of analytical methods for biological molecules to determine concentration and critical quality attributes.
- Experience of assay automation for cell based and biochemical assays.
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.
We have three ex vivo gene therapy products in late stage development. More recently, GSK has secured 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 Rare Diseases and Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies in other therapeutic areas.
A highly motivated, independent individual with a track record of developing and implementing novel downstream bioprocessing strategies is sought to work within this team. Your duties will include and are not limited to:
- Work collaboratively with Cell & Gene Therapy Platform Development CMC teams vector, upstream, analytical and cell process development scientists to establish robust methods for the analysis of viral vectors (lentivirus and AAV).
- Define and execute experimental strategies to establish a lentivirus/AAV downstream processing platforms in-process testing and controls to deliver high lentivirus recoveries whilst maintaining product quality.
- Contribute to the definition and delivery of downstream process development programmes outsourced to external Contract Manufacturing Organisations.
- Define, develop and validate innovative technologies and approaches to make step changes in viral vector in process control and analysis.
- Support development of a portfolio of ex-vivo gene therapies from early to late stage by providing expert input to project teams, directing development work, reviewing data, supporting regulatory interactions.
- Engage with external cell-gene therapy process/manufacturing and analytocal experts.
- Maintain awareness of external technology and patent landscape as well as competitor process technology activity.
- Develop an understanding of and the practical skills to conduct viral vector downstream processing experiments at both lab and process (50L/200L) scale.
You will have:
- Experience in assay development and the experience to trouble shoot both cell based and biochemical assays across a number of detection platforms.
- A track record of on time delivery of high quality decision making data to project teams.
- Experience of in-process analytical methods and determining critical process parameters (CPP) ideally for viral vectors.
- Experience with lentivirus or AAV purification would be an advantage.
- Experience of assay/process transfer and cGMP manufacturing would be an advantage.
- Excellent communication and project management skills to facilitate interactions with internal groups and with external collaborators and partners.
The successful candidate will report to the Scientific Leader of Downstream Process Development within Cell & Gene Therapy Platform CMC.
When applying for this role, please use the 'cover letter' of the application to describe how you meet the competencies required for this role, or how your current skills are transferable to the 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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 27th August 2017
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies 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.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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