Position Summary
Sunday-Thursday or Tuesday-Saturday
We are seeking an innovative and highly motivated Scientist in Analytical Operations who will advance the development of our cell therapy manufacturing platform. The primary focus of this position is to support the execution of analytical methods used to characterize and release cell-based therapies. The ideal candidate should have strong technical expertise in cell therapy analytical methods.
This is a multidisciplinary role as this individual will interface across various departments at the company (process development, quality, software and hardware engineers, automation engineers) on a daily basis. The successful candidate will be well versed in analytical operation and automation for cell therapy.
The 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
- Perform routine and non-routine analysis on in-process, raw materials, finished products, and stability samples using various analytical techniques such as flow cytometry, qPCR, multiplexing ELISA, and other methods as required
- Execute and support analytical method transfer and qualification from internal and external partners
- Train other analysts to perform laboratory procedures and assays as needed
- Maintain high standards of analytical operations, ensuring accuracy and compliance with GLP and safety requirements
- Assist in the preparation and review of technical reports, including assay results, Certificate of Analysis, and other data packages
- Assist troubleshooting efforts for assay or operational issues
- Maintain laboratory notebooks, standard operating procedures (SOPs), and ensure compliance with company quality standards
- Perform equipment validation, calibration, maintenance, and troubleshooting
- Other duties as assigned
Requirements
- Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 3+ years of analytical development or operation experience, preferably in the cell and gene therapy field
- Strong understanding in T-cell, HSC, B, or other immune cell therapy modality
- Extensive hands-on experience with one or more of the following: BD FACSCanto. BD FACSLyrics, Cytek Aurora, Cytek Northern Lights, BioRad CFX series or multimode microplate reader is a must
- Hands-on experience with high-dimensional flow cytometry, real-time PCR, multiplexing ELISA and aseptic technique is highly preferred
- Excellent verbal and written communication skills; Able to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences
- Knowledge and understanding of cGMP regulations and ICH guidelines preferred
- Self-awareness, integrity, authenticity, enthusiasm 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.
