• Reviewing process development and manufacturing histories to lead and deliver process risk assessments to define process attributes for inclusion in a laboratory process characterization (LPC) program(s).
• Design, execution and reporting of complex process LPC program(s).
• Work collaboratively with CGT scientific leads - Process and Platform Development, Process Engineering, Cell Process Development, Analytical Development, Formulation Development and Manufacturing to deliver LPC, Process Validation and process development projects.
• Technology transfer of assigned project's processes to manufacturing facilities.
• Propose, define, develop and validate innovative technologies and approaches to make step changes in LPC efficiency.
• Contribute to the definition and delivery of process development programmes outsourced to external Contract Manufacturing Organizations.
• Support the development of a portfolio of ex-vivo gene therapies from early to late stage by providing input to project teams, directing development work, reviewing data, supporting regulatory interactions.
• Engage with external cell-gene therapy process/manufacturing experts.
• Maintain awareness of novel technologies that have potential to impact LPC.
• PhD in Biochemical Engineering, Biological sciences, or related field with at least 3 years' experience in the development and process characterization of cell culture-based biologics (upstream and/or downstream processing) or cell therapy manufacturing processes
• Bachelors or Master's degree with at least 7 years' experience in experience in the development and process characterization of cell culture based biologics (upstream and/or downstream processing) or cell therapy manufacturing processes
• Experienced in the development and optimization viral vector-based manufacturing processes
• Experienced in process risk assessments, definition and execution of complex laboratory process characterization studies
• Experience in the use of statistical experimental design and data analysis
• Prior leadership/management experience
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.
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: