About the role
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, 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.
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
Create project plans, timelines, and reports to inform project execution; address blockers and challenges during 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, prepare presentations and present technical results
Identify and investigate process deviations and non-conformances, document findings and implement effective corrective and preventive actions
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 evolving technology
Self-awareness, integrity, authenticity, and a growth mindset
