Sr. Scientist, Downstream Process Development

Basic qualifications:

  • PhD or equivalent experience in Biological Sciences.
  • Experience of downstream process development for viral vectors, biopharmaceuticals or vaccines. Or experience in purification at lab scale and the willingness to learn about viral vector purification and scale up (up to 200L).

Preferred qualifications:

  • Experienced in optimisation and scale up of downstream processes for the production of clinical grade lentivirus or adeno-associated virus (AAV).
  • Experience in cell culture harvest strategies, chromatography resin screening and optimisation, ultrafiltration/diafiltration processes to isolate high-quality viral particles (lentiviral or AAV).
  • Ability to identify and implement novel downstream manufacturing platforms.
  • Experience of sterile filtration and methods for aseptic filling.

Details:

Grade 8 position

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 CMC vector, upstream, analytical and cell process development scientists to establish robust downstream processes, for the purification of viral vectors (lenti and AAV)
  • Define and execute experimental strategies to establish a lentivirus downstream processing platforms including in-process testing/controls delivering 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 lentivirus recovery/purification efficiency
  • Support development of a portfolio of ex-vivo gene therapies from early to late stage by providing downstream 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 as well as competitor process technology activity

You will have:

  • Experience in downstream process development – primary separations, ultrafiltration/diafiltration, chromatography resin screening, purification development and optimisation. Or extensive expreience in lab scale purification and the willingness to learn about viral vector purification and scale up (up to 200L).
  • A track record in the development/scale-up of biologics. Experience with lentivirus or AAV purification would be an advantage.
  • Experience of in-process analytical methods and determining critical process parameters (CPP) ideally for viral vectors.
  • 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 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, 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.

If requiring an adjustment for a disability, once selected for interview you may contact [email protected]

Please note that the closing date for applications to this vacancy is :17th August 2017

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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