Associate Scientist, Process Development

The Associate Scientist, Process Development at GreenLight BioSciences in Durham, NC will serve as a key member and technical leader of the process development team and support their overall mission of delivering high performance RNA production processes and products to the market. Specific responsibilities include: Support early-stage product development by performing laboratory scale fermentation, RNA production and downstream processing; Run 10 L fermentation experiment to produce plasmid DNA using strains developed by strain engineering team; Collect samples from fermentation experiment and assess process metrics such as plasmid DNA titer, plasmid DNA yield and quality; Perform downstream unit operations to recover plasmid DNA; Run 10 L RNA synthesis experiment using the plasmid DNA and assess process metrics such as RNA titer, yield and purity; Troubleshoot and identify opportunities for improvements in RNA production process by doing DoE based optimization experiments; Do statistically designed multifactorial optimization experiment i.e., Design of Experiment (DoE); Design, plan, execute the experiment, collect samples and run analytical methods for RNA titer, yield, analyze the data, fit curves, make model, do model predictions using statistical data analysis tool; Validate the model prediction, test reproducibility and robustness of the optimized RNA synthesis process conditions; Lead development of next generation processes to improve RNA production metrics; Using DoE and rationally designed experiments, identify the parameters limiting performance of RNA synthesis process; Formulate strategies to address the limitations such as developing new processes, identifying better raw materials, etc., to improve RNA production metrics; Create tasks, delegate and supervise team members towards completion of project goals; Develop, author and implement Standard Operating Procedures (SOPs) for process development activities; Write protocols and development reports for the new processes; Document in Quality Management System; train team members on the new protocols; Scale-up and tech transfer bench-scale processes to pilot production scale; Demonstrate scale-up by evaluating the new process in 10 L scale; Train production team members; Perform and report on procedures to quantitatively measure analytes (DNA, RNA, proteins, ions, etc.,) in a variety of matrices for analytical testing support; Run RNA analysis methods such as RNA concentration, RNA purity; Run DNA analysis methods such as restriction digestion and agarose gel electrophoresis; Run HPLC for small molecules, DNA, RNA; Make data driven decisions and identifies root causes to help solve problems and achieve opportunities; Test assays on different lots of DNA, enzyme samples to evaluate batch-to-batch variability; Identify causes for variability using the assay data; Work collaboratively with operations and quality management team members and communicate effectively to accomplish project goals and milestones; Work with cross-functional teams such as Strain Engineering, Manufacturing, QA/QC; and Plan data review meetings, present results and conclusions, suggest directions and next steps 

REQUIREMENTS: B.S. in Chemical Engineering, Biochemistry or related field, plus 24 months of experience or similar role in strain engineering field for aseptic techniques, bacterial culture, extraction and characterization of DNA, UV/VIS absorbance, gel electrophoresis, sequencing data analysis is required. Such experience must include: 12 months of experience as a research associate or similar role in process development handling lab-scale bioreactors for running fermentation, downstream processing equipment such as cell harvest by centrifugation, TFF, DNA column chromatography purification; 12 months of experience as a research associate or similar role handling analytical equipment such as HPLC to quantify DNA, RNA, organic acids; and 12 months of experience working with electronic lab notebook, laboratory information management system and statistical software such as GMP.