Associate Scientist, Process Development (I,II,III)

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

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