Director, Cell Process Development
PhD 7 plus years or BS/MS with 10 plus years equivalent experience in Biological sciences, Biochemical Engineering.
Experience in the development and process characterisation of cell culture based biologics or cell therapy manufacturing processes
Experienced in the development and optimisation of stem cell and/or T-cell ex-vivo cell product manufacturing processes
Experienced in process risk assessments, definition and execution of complex laboratory process characterisation studies
Experience of leading a team of cell process development scientists
Experience in the use of statistical experimental design and data analysis.
Excellent communication and project management skills to facilitate interactions with internal groups and with external collaborators and partners.
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. The progression of our product portfolio together with the maturation of the emerging gene therapy technologies requires GSK to increase our investment in this space and establish an 'end-to-end' leading platform. This will enable delivery of our 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.
GSK's Cell & Gene Therapy (CGT) Platform Development Group which is responsible for delivering the Chemistry, Manufacturing and Controls (CMC) aspects of the projects from early phase to launch and the development of innovative improvements to the design and manufacture of cell and gene therapy medicines is being expanded.
If you are a highly creative and motivated individual interested in leading the US based Cell Process Characterisation & Projects (CPC&P) team, then please read on. The successful candidate will use their experience of biologics and/or ex-vivo cell process development/process characterisation to establish, grow and lead a team responsible for (i) Laboratory process characterisation programmes relating to ex-vivo cell product manufacturing processes and (ii) Support cell product projects from clinical development through to file/commercialization. The CPC&P team, which you will help identify, will work closely with CGT's Validation Life Cycle Management (VLM) team to support Process Validation activities.
The CPC&P team will support clinical development of disease specific cell product projects assigned to the team by implementing platform processes developed by the Cell Process Development & Projects (CPD&P) team (UK based). The CPC&P (US) team will work closely with CPD&P (UK) team to ensure jointly that leading ex-vivo cell process capability is established and maintained.
It will be exciting for you to translate existing laboratory characterization approaches and, as required, take creative methods to establish leading regulatory compliant capability in ex-vivo cell process laboratory characterization. You'll need to understand Design Space verification, definition of CQA's, CPP's, and other related concepts. If you have recruited and identified a team that would certainly be an advantage.
Some of your exciting duties will include and are not limited to:
Reviewing cell process development and manufacturing histories to lead and deliver process risk assessments leading to design, execution and reporting of complex ex-vivo cell process LPC program(s).
Working collaboratively with CGT scientific leads to deliver LPC, Process Validation and cell product projects.
Support the development of a portfolio of ex-vivo gene therapies from early to late stage by providing input to project teams and supporting regulatory interactions.
Technology transfer of assigned project's cell processes to internal and external manufacturing facilities.
You will have:
Significant experience in biologics and/or cell product processes – development and/or manufacturing ideally ex-vivo stem cell or T-cell processes with experience of in-process analysis techniques such as multi-parameter flow cytometry.
You will report to the Head of Process Development within CGT and will be based at GSK's Upper Merion (US) site in King of Prussia, PA.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet align with the requirements and interests of this exciting opportunity at GSK>
You may apply for this position online by selecting the Apply now button.
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