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Associate Scientist, Process Development
Cellares
South San Francisco, CA, USA
Posted on Oct 15, 2024
Position Summary
Cellares is seeking an innovative and highly motivated Associate Scientist to join the Process Development team. This individual will interface across many parts of the company and contribute significantly to the development of our advanced cell therapy manufacturing platform.
The primary focus of this position is to design and execute experiments that drive the continuous improvement of the Cellares platform. The ideal candidate will be well-versed in process development techniques and methodologies, technology transfer, method scale up and troubleshooting, as well as engineering principles and tools.
The successful 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
- Provide hands-on support to small-scale and scale-up experiments and overall development of the Cellares advanced cell therapy manufacturing platform
- Interpret and adapt a cell therapy manufacturing process from a client to the Cellares platform; design and execute experiments related to workflow development and scale-up
- Develop process diagrams and flowcharts for novel and existing processes with minimal oversight
- Create project plan, timeline, and report on timelines during project execution; address blockers and challenges during the execution
- Perform primary cell line maintenance and leukopak processing, including isolation, activation, gene modification, expansion and cryopreservation
- Draft and review work instructions, standard operating procedures, test plans, and reports
- Generate and review process documentation including but not limited to Manufacturing Batch Records and Bill of Materials (BOM)
- Analyze and interpret process data, generate presentations, present technical results at departmental meetings and data review meetings
- Identify and investigate process deviations and non-conformances, document findings and implement effective corrective and preventive actions
- Perform routine laboratory activities including ordering, restocking, and equipment qualification/maintenance.
Requirements
- BS or MS in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field with 4-10 years of process development experience in the cell and gene therapy field
- Experience in aseptic technique and primary immune cell culture
- Extensive experience using and troubleshooting semi-automated instruments and laboratory information management systems
- Strong problem-solving skills and attention to detail
- Strong technical writing skills and experience authoring SOPs and reports
- Familiarity with cell therapy analytical testing methods, such as flow cytometry and cell-based assays is preferred
- Creative, self-motivated, eager to take on a wide variety of tasks and grow with the evolving technology
- 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.