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 that drive the continuous improvement of 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 with minimal oversight
- Create project plan, timeline, and report on timelines during project execution; address blockers and challenges during the 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, generate presentations, present technical results at departmental meetings and data review meetings
- Identify and investigate process deviations and non-conformances, document findings and implement effective corrective and preventive actions
- Perform routine laboratory activities including ordering, restocking, and equipment qualification/maintenance.
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 the evolving technology
- Self-awareness, integrity, authenticity, and a growth mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
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.
