WD24345: Investigator – Upstream Process Development
Basic Qualifications
· PhD or equivalent experience in Biological sciences, Biochemical Engineering
· Experience in the development and optimisation of upstream mammalian cell culture/viral manufacturing processes
Preferred Qualifications
· Experienced in optimisation and scale up of mammalian manufacturing processes for the clinical grade production of lentivirus
· Experience in HEK293 lentivirus production using stable and/or transient systems
· Experience in mammalian cell culture media/feed development, fed-batch/perfusion culture
· Ability to implement novel bioreactor manufacturing platforms
Details
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 Advanced Therapy Delivery Team (ATD) is being rapidly 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 and gene therapy manufacture.
We have three ex-vivo gene therapy products in late stage development. More recently GSK has a significant collaboration in the T-cell immunotherapy filed with Adaptimmune and other licensing/partnership opportunities are being pursued. The progression of our own portfolio together with the maturation of the emerging gene therapy technologies created an imperative for GSK to now increase our investment in this space and establish an `end-to-end’ leading 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 in other therapeutic areas.
A highly motivated, independent individual with a track record of developing and implementing novel bioprocessing strategies is sought to work within this team. Your duties will include and are not limited to:
· Work collaboratively with ATD scientists- vector, downstream processing, cell processing and analytical development to deliver robust, efficient, scaleable, validatable upstream manufacturing processes for lentivirus production
· Define and execute experimental strategies to establish lentivirus upstream production platforms including in-process testing/controls delivering high titre lentivirus whilst maintaining product quality
· Contribute to the definition and delivery of upstream process development programmes outsourced to external Contract Manufacturing Organisations
· Develop and validate innovative technologies and approaches to make step changes in lentivirus production efficiency
· Support the development of a portfolio of ex-vivo gene therapies from early to late stage by providing upstream expert input to project teams, directing development work, reviewing data, supporting regulatory interactions
· Engage with external cell-gene therapy process/manufacturing experts
· Maintain awareness of external technology and patent landscape and competitor process technology activity
You will have:
· Experience in mammalian cell culture upstream process development and optimisation in stirred tank bioreactors. Experience of the culture of HEK293 cells would be an advantage.
· A track record in the development/scale-up of biologics. Experience with lentivirus or AAV vectors or virus production using cell culture would be an advantage.
· Experience of in-process analytical methods. Experience in determining critical process parameters (CPP) ideally for viral vectors would be an advantage.
· Experience of 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 Head of Process Development within Advanced Therapy Delivery and will be based at Stevenage in the UK.
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.
Thank you for interest in this opportunity….
Don’t forget to mention Naturejobs when applying.
Source: Nature Jobs
