Cellares is seeking a highly motivated, experienced Systems Integration Engineer to work on complex instrumentation systems, including testing and development, to support the automated cell therapy manufacturing operations.
This is a multidisciplinary role. This individual will interface with many parts of the company and contribute significantly to developing advanced cell therapy systems.
The ideal candidate will have demonstrated experience in biomedical-related instruments and consumables development, integration, and verification activities. As a Systems Integration Engineer, you are expected to readily learn and adapt to Cell Shuttle technologies, take ownership of various tasks, and successfully drive them to completion. In your daily work, you will provide in-depth analysis for system characterization and troubleshooting, and help guide important decisions for continuous improvement projects.
Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle various challenges as the company grows.
Responsibilities
- Technical lead to perform hands-on system characterization, integration, verification testing, troubleshooting, root-cause investigation, and continuous improvement of Cellares technology platforms
- Work closely with the Hardware, Software, Firmware, Process, and Manufacturing teams to perform system characterization, testing, and continuous system improvement
- Design and execute complex experiments, following scientific principles and statistical approaches, to support the development and characterization of customer processes
- Author and present quality technical documents, procedures, and reports
- Produce technical reference documentation and reports, and provide training and assistance for the operations team
- Interface closely and actively with cross-functional teams, and self-motivated to drive given tasks to completion
Requirements
- BS in Engineering, Bioengineering, Physics, or related field with 5+ years of extensive, hands-on experience in developing analytical instrumentation and biotech automation
- OR MS or PhD in Engineering, Bioengineering, Physics, or related field with 3+ years of extensive, hands-on experience in developing analytical instrumentation and biotech automation
- Extensive hands-on experience in integration testing and troubleshooting in highly complex instrumentation systems that combine fluidic handling, electronic sensors, gas mixing, and robotics
- Hands-on experience with autologous and allogeneic cell therapy manufacturing processes is a plus
- Experience with scripting languages (MATLAB, Python, JMP, etc.) for modeling, simulation, and data processing
- Prior experience with ISO regulations, cGMP, QMS, and IEC 61010 standards is preferred
- Excellent verbal, written, presentation, and interpersonal skills
- Strong analytical and problem-solving mindset
- Self-awareness, integrity, authenticity, and a growth mindset
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.