Associate Scientist, RNA Pilot Manufacturing
Core
Operating an integrated RNA Pilot Manufacturing operation to deliver high-quality material for early and late-stage development programs.
Role type
Associate Scientist (Manufacturing Operations)
Builds
Non-GMP RNA manufacturing material for various program needs
Domain
Biopharmaceuticals / RNA Therapeutics
Required skills
RNA manufacturing operations, bioreactor operation, chromatography, filtration, technology transfer, process unit operations, KPI management, production documentation, RNA analytics, biophysical characterization (HPLC, CE, ELISAs, cell-based assays), root-cause analysis, corrective and preventive actions, ELN workflows, multivariate data analysis
Preferred skills
Prior management and mentorship experience, continuous improvement mindset
Technologies
ELN workflows, multivariate data analysis tools, HPLC, CE, ELISAs, cell-based assays
Responsibilities
Support and execute RNA manufacturing operations supporting nonGMP manufacturing activities; Work in an agile development manufacturing model in the RNA space capable of rapidly delivering material for various program needs; Ensure manufacturing operations are executed in a phase-appropriate manner, balancing speed, compliance, scientific rigor, and operational discipline; Partner with analytical testing laboratories to ensure sample submission, investigation support, and timely release of material; Enable technical problem-solving during manufacturing campaigns, including real-time escalation, root-cause analysis, and implementation of corrective and preventive actions; Maintain systems for tracking process performance using ELN workflows and multivariate data analysis tools; Ensure learnings from manufacturing activities are captured, communicated, and incorporated into future strategies.