Position Summary
Cellares is seeking an innovative and highly motivated Senior Analytical Transfer Scientist with expertise in method transfer, validation and development of bioanalytical methods to support the Cell therapy Analytical Science and Technology team. This individual will interface cross-functionally across the Quality control, Manufacturing Science and Technology, Quality, Analytical Development team, Regulatory and serve as the analytical subject matter expert (SME) in supporting product development and regulatory submission. This individual will contribute significantly in method transfer activities, validation, method performance, reagent or critical reagent qualification of our advanced cell therapy analytical Cell Q platform.
The primary focus of this position is to design and implement new cell therapy method validation, and to transfer and drive continuous improvement of the Cellares analytical platform. The ideal candidate will be a technical leader and cross-functional collaborator with demonstrated expertise in developing robust autologous and allogeneic cell therapy methods.
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
- Lead the method transfer, Validation and optimization (if necessary) of analytical methods for cell and gene therapies, including assays for identity, potency, purity, and safety (e.g., qPCR/ddPCR, flow cytometry, ELISA, cell-based assays, viral vector quantification)
- Oversee the transfer of analytical methods to internal or external Quality Control laboratories, ensuring adherence to GMP and regulatory guidelines
- Execute advanced testing for product characterization, process development, stability testing, and comparability assessments to align with FDA, EMA, and ICH standards
- Analyze complex bioanalytical data and prepare technical reports, protocols, and analytical sections for regulatory submissions, including IND, BLA, and MAA filings
- Ensure all analytical methods comply with cGMP, FDA, EMA, and ICH guidelines, providing technical support during regulatory submissions and inquiries
- Collaborate closely with Process Development, Manufacturing, Quality Control, and R&D teams to provide analytical support across product development stages
- Stay informed about the latest advancements in analytical technologies and evaluate new tools to enhance the team’s capabilities
Requirements
- Master's or Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or a related field with 6-14 years of relevant experience in cell and gene therapy
- Strong experience with bioanalytical techniques, including qPCR/ddPCR, flow cytometry, ELISA, cell-based potency assays, and viral vector assays (AAV, lentivirus)
- Experience in method development, validation, and transfer under GMP conditions for cell and gene therapy products
- Knowledge of regulatory filing requirements for viral vectors, gene-modified cells, and advanced therapeutic products
- Proficiency in data analysis using software tools like FlowJo, JMP, and GraphPad Prism
- Experience working in cross-functional teams in a fast-paced, regulatory-driven environment
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.
