Scientist, Process Development (I,II,II)

Responsibilities

• 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 team
• Author high-quality technical documents, procedures, and reports
• Analyze and present technical results at departmental meetings
• Perform routine laboratory activities including ordering, restocking, and equipment qualification/maintenance
• 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 process, provide technical insights and support in troubleshooting and root cause investigations

Requirements

• 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 strongly preferred
• Extensive experience designing scale-up experiments and troubleshooting semi-automated instruments
• Hands-on experience with both autologous and 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 the evolving technology