ATD: Process Engineer, Open to flexibility
ATD: Process Engineer, Open to flexibility
We are seeking a highly motivated, independent Senior Process Engineer with a track record of manufacturing process engineering for our team. Our Cell & Gene Therapy Platform CMC team is being expanded to support an increasing portfolio of cell and gene therapies. Our 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 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 as well as ensuring that GSK is able to capture the potential of the emerging technologies in other therapeutic areas.
Your duties as a Senior Process Engineer will include and are not limited to:
- Work collaboratively with Cell & Gene Therapy scientific leads, process/analytical development scientists, QC, Operations and CMC providing process engineering expertise to ensure delivery of robust, capable, efficient, scalable manufacturing processes for production
- Apply principles of concurrent engineering to ensure manufacturability of processes developed by the process development team
- Ensure the health, safety, environmental and sustainability performance of our manufacturing processes
- Own definition and delivery of Process Transfer Documents and lead effective technology transfer programmes to both in-house and external (CMO) manufacturing facilities
- Propose, define, develop and validate innovative manufacturing and automation technologies and approaches to make step changes in manufacturability of cell-gene therapy products
- Engage with external cell-gene therapy process engineering and manufacturing experts
- Maintain awareness of new, emerging manufacturing technologies and competitor process technology/manufacturing activity
- Bachelors degree in Chemical Engineering, Biochemical Engineering, Materials Engineering or other related engineering or scientific discipline
- Extensive experience in biopharmaceutical manufacturing processes
- Experience of technology transfer, establishment, qualification in GMP biopharmaceutical industry setting
- Significant experience in the development and manufacture of biotherapeutics or medical devices 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 would be an advantage.
- Excellent communication and project management skills to facilitate interactions with internal groups and with external collaborators and partners.
- Masters and/or PhD in Chemical Engineering, Biochemical Engineering, Materials Engineering or other related engineering or scientific discipline
- Experience with process development using principles of design for manufacturability, Quality by Design (QbD) in the biotherapeutics or medical device or cell therapy industries
- Experience of manufacturing using single use systems
- Expertise in the use of statistical experimental design, data analysis and development of highly capable manufacturing processes
- Excellent understanding of current Good Manufacturing Practices (cGMP)
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires
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