Position Summary
Cellares is seeking an innovative and highly motivated Associate Scientist 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, as well as develop standard operating procedures and processes for the Cellares platform. The ideal candidate will be well-versed in process development techniques and methodologies, technology transfer, method scale up and troubleshooting, as well as engineering principles and tools.
The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
Provide hands-on support to small-scale and scale-up experiments and overall development of the Cellares advanced cell therapy manufacturing platform
Interpret and adapt a cell therapy manufacturing process from a client to the Cellares platform; design and execute experiments related to workflow development and scale-up
Develop process diagrams and flowcharts for novel and existing processes
Create project plans, timelines, and reports to inform project execution; address blockers and challenges during execution
Perform primary cell line maintenance and leukopak processing, including isolation, activation, gene modification, expansion and cryopreservation
Draft and review work instructions, standard operating procedures, test plans, and reports
Generate and review process documentation including but not limited to Manufacturing Batch Records and Bill of Materials (BOM)
Analyze and interpret process data, prepare presentations and present technical results
Identify and investigate process deviations and non-conformances, document findings and implement effective corrective and preventive actions
Requirements
BS or MS in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 4-10 years of process development experience in the cell and gene therapy field
Experience in aseptic technique and primary immune cell culture
Extensive experience using and troubleshooting semi-automated instruments and laboratory information management systems
Strong problem-solving skills and attention to detail
Strong technical writing skills and experience authoring SOPs and reports
Familiarity with cell therapy analytical testing methods, such as flow cytometry and cell-based assays is preferred
Creative, self-motivated, eager to take on a wide variety of tasks and grow with evolving technology
Self-awareness, integrity, authenticity, and a growth mindset
Skills Required
- BS or MS in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 4-10 years of process development experience in cell and gene therapy
- Experience in aseptic technique and primary immune cell culture
- Extensive experience using and troubleshooting semi-automated instruments and laboratory information management systems (LIMS)
- Strong problem-solving skills and attention to detail
- Strong technical writing skills and experience authoring SOPs and reports
- Familiarity with cell therapy analytical testing methods such as flow cytometry and cell-based assays
- Creative, self-motivated, eager to take on a wide variety of tasks and grow with evolving technology
- Self-awareness, integrity, authenticity, and a growth mindset
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.
