Position Summary
We are seeking an innovative and highly motivated Manager in Analytical Operations who will manage a team of scientists and analysts, advancing the development of our cell therapy manufacturing platform. The primary focus of this position is to ensure the successful execution of assays and data analysis of various analytical methods to characterize cell-based therapies.
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 approaches.
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
- Lead and manage the analytical operations team, including assay scientists and analysts
- Schedule/Manage routine and non-routine analysis of in-process, raw materials, finished goods, or stability samples
- Manage the transfer and execution of methods from internal and external partners
- Manage training of other analysts to perform laboratory procedures and assays
- Ensure analytical operation is held to GLP and safety standards
- Ensure proper data capture, analysis, and reporting
- Review and approve assay results and technical reports
- Lead troubleshooting efforts for assay or operational issues
- Create, review and approve Certificate of Analysis
- Review and approve data to ensure accuracy and regulatory compliance
- Behave as a working backup AO analyst for testing activities as needed
- Manage and grow a phase appropriate team of Analytical Operation personnel
- Manage equipment validation, calibration, maintenance, and troubleshooting
- Assist in the preparation of dossiers and data packages in support of Cellares' products for regulatory agencies
- Other duties as assigned
Requirements
- Bachelor's, Master's, or PhD in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 6-20 years of analytical development or operation experience in the cell and gene therapy field
- Subject-matter expert in T-cell, HSC, B, or other immune cell therapy modality
- Extensive hands-on experience with the following: BD FACSCanto/FACSLyrics, Cytek Aurora/Northern Lights, BioRad CFX series and multimode microplate reader is a must
- Hands-on experience with high-dimensional flow cytometry, 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.
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