Position Summary
Cellares is seeking an innovative and highly motivated Scientist with expertise in cell therapy manufacturing to join the Process Development team. This individual will interface across many parts of the company and contribute significantly to the development of our advanced cell therapy manufacturing platform.
The primary focus of this position is to design and execute experiments that drive the continuous improvement of the Cellares platform. The ideal candidate will be a strong technical contributor and cross-functional collaborator with demonstrated experience developing robust autologous and allogeneic cell therapy processes.
Candidates should also enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
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 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
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 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
Skills Required
- Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with process development experience
- Extensive experience designing small-scale and/or scale-up experiments and troubleshooting processes (including DOE)
- Hands-on experience with autologous and/or allogeneic cell therapy manufacturing processes
- Experience working with semi-automated instruments and implementing/optimizing processes on such platforms
- Familiarity working in a GMP and/or clinical manufacturing setting
- Experience with flow cytometry and cell-based assays
- Strong understanding of cell biology and immunology
- Excellent verbal and written communication skills; ability to interpret, summarize, and present scientific results
- Experience authoring technical documents, procedures, reports, and developing training materials
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.
