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.
Top Skills
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
.png)
