We are seeking a process development scientist to join the messenger-RNA (mRNA) process development team. The successful candidate will be contributing to process characterization and tech transfer of programs in clinical development. In this role, the successful candidate will have knowledge of GMP regulatory expectations for biologic gene edited material. Direct experience developing, characterizing, scaling, or supporting GMP processes for mRNA is strongly preferred.
- Design, execute, and analyze experiments to develop and optimize mRNA process characterization techniques.
- Evaluate process performance and identify opportunities for productivity improvements.
- Support the transition of development-stage processes toward GMP-compliant manufacturing by establishing scalable, robust, and well-characterized process parameters.
- Develop scalable processes for plasmid DNA production using fermentation systems.
- Operate and troubleshoot bioreactors/fermenters.
- Develop, execute, optimize, and troubleshoot in vitro transcription (IVT) process development activities.
- Develop, execute, optimize, and troubleshoot chromatography systems including Cytiva AKTA Avant for purification process development and scale-up studies.
- Develop, execute, optimize, and troubleshoot chromatography systems including Agilent 1260 HPLC/UHPLC systems for nucleic acid analysis, impurity profiling, quantitation, and process characterization.
- Analyze and interpret data to support process optimization, troubleshooting, and technology transfer activities.
- Author and review GMP-relevant technical reports, protocols, batch records, and development summaries.
- Present findings to management and project teams.
- Uphold lab safety to the highest level of standards.