Senior Research Associate, Process Development (I, II, III)
San Francisco, CA, USA
Posted on Friday, November 4, 2022
Cellares is seeking an innovative and highly motivated Senior Research Associate 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, as well as develop standard operating procedures and processes for 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.
- 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.
- 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 creating the future of cell therapy manufacturing. The company is developing an innovative cell therapy manufacturing solution that is robust, cost-effective and scalable so that cell therapies are more affordable and widely available to patients in need. Our multidisciplinary team comes together from diverse backgrounds with a shared passion for accelerating access to life-saving cell therapies. We value integrity, curiosity, the courage to grow and embrace change. At Cellares, you will collaborate with a world class team of engineers, scientists, and business leaders who are as excited about improving the world as you are.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
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