Senior Scientist, RNA Pilot Manufacturing
Core
Lead an integrated RNA Pilot Manufacturing operation to deliver high-quality material with agility and speed across early and late-stage development.
Role type
Senior Scientist, RNA Pilot Manufacturing
Builds
Non-GMP RNA drug substance for various program needs
Domain
Biopharmaceuticals / RNA therapeutics
Required skills
RNA manufacturing operations, bioreactor operations, chromatography, filtration, in vitro transcription scaling, technology transfer, CRO management, production scheduling, cross-functional coordination, RNA analytics, biophysical characterization, process improvement
Preferred skills
People management and mentorship, independent work in matrixed environments, influencing cross-functional stakeholders
Technologies
ELN workflows, multivariate data analysis tools, HPLC, CE, ELISAs, cell based assays
Responsibilities
Lead and execute RNA manufacturing operations supporting nonGMP manufacturing activities; Provide leadership for the RNA Pilot ensuring seamless understanding between process development and manufacturing execution; Build and operate an agile development manufacturing model; Ensure manufacturing operations are executed in a phase-appropriate manner; Partner with analytical testing laboratories to ensure testing readiness and timely release; Ensure operational readiness across people, process, materials, equipment, facilities, and documentation; Manage Pilot lab timelines and raw material inventory; Drive technical problem-solving during manufacturing campaigns; Establish and manage systems for tracking process performance; Ensure learnings from manufacturing activities are captured and incorporated into future strategies.