Cellares
Biotech
AssociateScientist,ProcessDevelopment(I,II,III)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate Scientist, Process Development (I, II, III) at Cellares. Skills: Process development, Cell therapy manufacturing. Provide hands-on support to experiments. Support scale-up experiments”
Industry & Context.
Problem-solving skills; Troubleshooting
What They're Looking For.
Must Have
BS or MS in Bioengineering, Chemical Engineering, Biology, Biochemistry, or related field, 4-10 years of process development experience, Experience in aseptic technique, Primary immune cell culture experience, Extensive experience using and troubleshooting semi-automated instruments, Extensive experience using and troubleshooting laboratory information management systems, Problem-solving skills, Attention to detail, Technical writing skills, Experience authoring SOPs, Experience authoring reports
Nice to Have
Familiarity with cell therapy analytical testing methods, Flow cytometry experience preferred, Cell-based assays experience preferred
What You'll Do.
Provide hands-on support to experiments
Support scale-up experiments
Support development of cell therapy manufacturing platform
Interpret cell therapy manufacturing process
Adapt cell therapy manufacturing process
Execute experiments for workflow development
Execute experiments for scale-up
Develop process diagrams
Develop flowcharts for novel processes
Develop flowcharts for existing processes
Address project blockers
Address project challenges
Perform primary cell line maintenance
Perform leukopak processing
Draft work instructions
Review work instructions
Draft standard operating procedures
Review standard operating procedures
Generate process documentation
Review process documentation
Generate Manufacturing Batch Records
Generate Bill of Materials
Interpret process data
Prepare presentations
Present technical results
Identify process deviations
Investigate process deviations
Identify non-conformances
Investigate non-conformances
Implement corrective actions
Implement preventive actions
How You'll Work.
Communication Scope
Technical writing; Present technical results
Process & Methodology
Project plans, Timelines
Full Job Description
## 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 ## Additional Information This is Cellares Cellares is the first Integrated Developme
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