Position Summary
We are seeking an innovative and highly motivated R&D Engineer, who will contribute significantly to the development of our advanced cell therapy manufacturing platform. The primary focus of this position will be the design, prototyping, production, and verification of highly complex plastic injection molded consumable assemblies. As an R&D Engineer, you will be responsible for component selection, design tasks, manufacturing coordination, sterilization coordination, and initial quality assurance efforts of both individual components, and finished assemblies. Additionally, you will be required to provide in-depth analysis and CAD data to help guide important decisions during design reviews.
This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world. The successful candidate will be experienced in the areas of plastic injection molding, material selection, and component selection for complex biomedical consumable device design. This is a hands-on position.
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
- Responsible for the design, development, prototyping, and volume manufacturing of high precision mechanical components & assemblies
- Design and development of manufacturing test fixtures as required
- Identify & interface with key component vendors (suppliers of tubing, valves, etc, that may be integrated into our consumable design)
- Interface with systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically
- Conduct design reviews and present fresh ideas, new technologies, and creative solutions to design problems
- Show proof of concept through rapid prototyping
- Work closely with the scientific team through the creation of verification/validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, reporting, and documentation
- Work with external companies as needed to outsource injection molding activities, and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, and concept & design followed by verification/validation
- Work with external companies as needed to outsource consumable assembly and sterilization activities through all phases of the projects
- Create comprehensive work instructions and manufacturing SOP’s as needed
Requirements
- Bachelor's degree in a relevant field with 5 years of experience or Master's degree in a relevant field with 3 years of experience
- 2+ years of hands-on experience with plastic injection molded fluidic systems including but not limited to component design, design optimization, mold design.
- 2+ years of experience designing and building one-time use tubing sets or consumables for the medical or biotech industry
- In-depth knowledge of materials science/plastics properties and metrology techniques
- Excellent verbal, written, presentation, and interpersonal skills. Strong analytical and problem-solving skills
- Prior experience with FDA regulations and ISO, cGMP, QMS standards & with USP class VI materials
- Develop, maintain, and optimize Python scripts for data analysis, manage version control using Git, and effectively present insights through visualizations and reports
- Knowledge and/or hands-on experience with machine shop tools
- Strong proficiency with SolidWorks CAD tools
- Work history with several successful iterations of molded components transferred successfully to volume manufacturing
- Working knowledge of manufacturing techniques, including: machining, injection molding, and bonding of consumables (ultrasonic welding, laser welding) for biotech components
- Desire to be part of a rapidly evolving organization with a compelling technology, and ready to take products and processes to the next level
- 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.
