Responsibilities
- Perform routine and non-routine analysis on in-process, raw materials, finished products, and stability samples using various analytical techniques such as flow cytometry, qPCR / digital PCR, ELISA
- Execute and support analytical method transfer and qualification from internal and external partners
- Train other analysts to perform laboratory procedures and assays as needed
- Maintain high standards of analytical operations, ensuring accuracy and compliance
- Assist in the preparation and review of technical reports, including assay results, Certificate of Analysis, and other data packages
- Assist troubleshooting efforts for assay or operational issues
- Maintain electronic lab notebook (ELN), standard operating procedures (SOPs), and ensure compliance with company quality standards
- Proficient in independent data analysis and visualization
- Perform equipment validation, calibration, maintenance, and troubleshooting
- Other duties as assigned
Requirements
- PhD in Molecular Biology, Cell Biology, Immunology, or a related field
- Minimum 2 years of hands-on cell therapy industry experience
- Demonstrated experience in method development, qualification, and transfer
- Proficient in data analysis and scientific presentation, with attention to detail and data integrity
- Effective communication and collaboration skills, with a commitment to scientific excellence
- Strong problem-solving skills and ability to troubleshoot complex assay issues
- Self-awareness, integrity, authenticity, enthusiasm 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.
