Scientist, Process Development (I,II,III)
TLDR
Design and execute experiments to drive continuous improvement of the cell therapy manufacturing platform, collaborating across teams to advance autologous and allogeneic processes.
Design and execute complex experiments using scientific principles and statistical approaches (DOE) to support the development of the Cellares platform
Interface internally and cross-functionally with Analytical Development, MSAT, Quality, Manufacturing, BD, Product, and Engineering to implement new processes and technologies as part of the core technology transfer and translation team
Author high-quality technical documents, procedures, and reports
Analyze and present technical results at departmental meetings
Gather and review system requirements, develop robust test plans, oversee and support execution of experiments
Develop training materials for scientific methods and techniques, train and onboard new hires
Serve as subject matter expert where appropriate for the cell and gene therapy processes
Provide technical insights and support in troubleshooting, root cause investigations and feedback to engineering teams on technology design and function
Bachelor's, Master's or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 0-15 years of process development experience in the cell and gene therapy field
Familiarity working on a GMP and/or Clinical Manufacturing setting preferred
Extensive experience designing small-scale and/or scale-up experiments and troubleshooting processes running on semi-automated instruments
Hands-on experience with autologous and/or allogeneic cell therapy manufacturing processes
Excellent verbal and written communication skills; able to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences
Experience with flow cytometry and cell based assays preferred
Strong understanding of cell biology and immunology
Creative, self-motivated, eager to take on a wide variety of tasks and grow with evolving technology
Cellares is pioneering the field of cell therapy manufacturing as the first Integrated Development and Manufacturing Organization (IDMO) focused on harnessing Industry 4.0 technologies. Its innovative Cell Shuttle platform automates and integrates the entire production process, enabling companies in academia, biotechnology, and pharmaceuticals to accelerate the delivery of life-saving therapies while reducing costs and operational failures.