Process Development: Process/Automation Engineer
- BSc or MSc and/or PhD in Engineering or Science related discipline
- Experience in biological manufacturing processes and or technology
- Experience of technology transfer, establishment, and/or qualification in a GP biopharmaceutical, instrument, or medical device industry setting
- Experience with process/analytical/technology development using principles of design for manufacturability, Quality by Design (QbD) in the bio therapeutics, medical device, instrument or cell therapy industries
- BSc or MSc and/or PhD in Chemical, Bio/Biochemical, Automation/, Systems Engineering or other engineering related discipline
- Experience in the automation of cell therapy processing and/or analytics unit operations
- Experience of manufacturing using single use systems
- Experience in the design and/or use of microfluidic devices for cell therapy processing and/or analytics unit operations
- Expertise in the use of statistical experimental design, data analysis and development of highly capable manufacturing processes
- Excellent understanding and experience in the use of current Good Manufacturing Practices (cGMP)
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.
StrimvelisTM gene therapy for ADA-SCID was approved in May 2016 via an MAA that supports patient access at the single site in Milan. We also have multiple other ex-vivo gene therapy products in late stage development. More recently GSK has a announced a significant collaboration in the T-cell immunotherapy with Adaptimmune and other licensing/partnership opportunities are being pursued. GSK's strategic collaboration with Miltenyi Biotec seeks to optimise the manufacture and delivery of these personalised therapies using increased automation and leading edge processing technology. 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 process and/or systems engineering is sought to work within this team. Your duties will include and are not limited to:
- Work collaboratively with C> scientific leads, process/analytical development scientists, QC, Operations, and CMC to ensure delivery of robust, capable, efficient, scalable, and validatable manufacturing processes for production.
- Work with internal and external collaborators, propose, define, develop and validate innovative manufacturing and automation technologies and approaches to make step changes in manufacturability of cell-gene therapy products.
- Apply principles of concurrent engineering to ensure manufacturability of processes developed by the process development team
- Ensure the health, safety and environmental performance of our manufacturing processes
- Contribute to the definition and delivery of development/manufacturing programmes outsourced to external Contract Manufacturing Organisations
- Support the 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 engineering and manufacturing experts
- Maintain awareness of new, emerging automation/manufacturing technologies and competitor process technology/manufacturing activity
You will have:
- Significant experience in the development, automation, and manufacture of biotherapeutics, medical devices, instruments, and/or cell therapy products
- A strong track record working closely with process development scientists to establish efficient clinical and commercial manufacturing processes.
- Experience of virus manufacturing or cell processing 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 Cell & Gene Therapy Engineering within C> and will be based at Upper Merion, PA in the US or Stevenage, Hertfordshire 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.
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