Position Summary
We are seeking an innovative and highly motivated Process Engineer on our MSAT team who will contribute significantly to establishing our IDMO Smart Factories.
This position is focused on supporting the development and implementation of automated cell therapy manufacturing processes. You will work closely with the Process Engineering Lead and other cross-functional teams to execute, develop, design, optimize, and validate processes to ensure efficient, high-quality, scalable manufacturing solutions.
This is a multidisciplinary role & this individual will interface across many parts of the company (with customers, scientists, researchers, and engineers) to develop the best solutions possible. Candidates 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
- Design and implement operational workflows to streamline manufacturing and reduce errors
- Participate in the execution of manufacturing study campaigns, working closely with cross-functional teams to ensure successful execution
- Assist in the design, execution, and analysis of process development studies to optimize cell therapy manufacturing processes
- Support the development and implementation of automated manufacturing processes using the Cellares platform
- Prepare and maintain technical documentation, including study protocols, reports, and standard operating procedures (SOPs)
- Collect and analyze process data to identify trends, troubleshoot issues, and recommend improvements
- Provide technical support during technology transfer, process validation, and routine manufacturing
- Collaborate with cross-functional teams, including Quality, Supply Chain, Manufacturing, and Analytical Sciences, to ensure successful process development and implementation
- Identify opportunities for process improvements and participate in continuous improvement initiatives to enhance manufacturing efficiency and product quality
Requirements
- Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, or a related field
- 0-4 years of experience in bioprocess engineering, cell therapy GMP manufacturing, or a related field
- Prior experience with automated manufacturing processes is a plus
- Knowledge of cell therapy manufacturing processes, including cell culture, separation, and purification
- Familiarity with bioprocessing equipment and automation systems
- Proficiency in data analysis tools (e.g., Excel, statistical software)
- Experience writing, reviewing and approving GMP documentation
- Experience troubleshooting complex technical issues
- Strong problem-solving skills with a hands-on approach
- Excellent communication and teamwork abilities
- Detail-oriented with strong organizational skills
- Ability to work in a fast-paced, dynamic environment
- Willingness to learn and adapt to new technologies and processes
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.
