Senior Scientist, Process Development (I,II,III)

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 and review technical documents, procedures and reports to ensure accuracy and quality
• Present technical and programmatic information to internal and client-facing stakeholders
• Coordinate day-to-day team efforts and provide technical training and guidance to junior team members
• 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 6-21 years of process development experience in the cell and gene therapy field
• Subject-matter expert in T cell, HSC, or other immune cell therapy modality
• Extensive hands-on experience with commercial cell processing instruments (Miltenyi Prodigy, Lonza Cocoon, Xuri Wave) relevant to cell selection/purification and expansion
• Familiarity with diverse cell editing technologies (LVV, RVV, LNP) and processes (transduction, transfection, electroporation, etc.) 
• 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
• Knowledge and understanding of cGMP regulations and ICH guidelines preferred
• Self-awareness, integrity, authenticity, and a growth mindset.