Senior Scientist, RNA Pilot Manufacturing

The RNA Process development team is seeking a Senior Scientist to lead an integrated RNA Pilot Manufacturing operation. This role will be responsible for delivering high-quality material with agility and speed across early and late-stage development.

This leader will be accountable for building and operating a phase-appropriate manufacturing model that enables rapid execution while maintaining quality, compliance, safety, and technical rigor. This role requires deep experience in a manufacturing environment, strong understanding of ALCOA principles, and the ability to lead cross-functional execution in a fast-paced, science-driven setting.

The Senior Scientist will partner closely with CMC functions including Analytical Development, Process Development, Quality and the GMP manufacturing facility to ensure seamless material delivery, technical readiness, operational excellence, and robust transfer of product and process knowledge across the manufacturing network.

• Lead and execute RNA manufacturing operations supporting nonGMP manufacturing activities.
• Provide leadership for the RNA Pilot, ensuring scientific and technical understanding is seamless between process development through manufacturing execution.
• Build and operate 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 testing readiness, sample flow, analytical timelines, investigation support, and timely release of material.
• Ensure operational readiness across people, process, materials, equipment, facilities, documentation, and testing prior to manufacturing execution.
• Manage Pilot lab timelines and raw material inventory to ensure timely delivery of nonGMP RNA drug substance.
• Drive technical problem-solving during manufacturing campaigns, including real-time escalation, root-cause analysis, and implementation of corrective and preventive actions.
• Establish and manage 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.

• Degree in Bio/Chemical Engineering, Bio/Chemistry, or related field
  • BS with 8+ years’ experience in science related disciplines
  • MS with 6+ years’ experience in science related disciplines
  • PhD with 2+ years’ experience in science related disciplines

• Experience in managing manufacturing timelines including raw material sourcing and inventory.
• Experience in process unit operations relevant to RNA manufacturing including bioreactors, chromatography, and filtration.
• Experience in scaling up in vitro transcription reactions.
• Knowledge and understanding of technology transfer from PD to the pilot facility and from the pilot facility to GMP manufacturing.
• Experience working with CROs to source phase appropriate DNA templates and other critical raw materials.
• Strong track record of implementing standardized operations, KPI management, and production documentation systems.
• Experience managing material flow, production scheduling, and cross-functional coordination.
• Experience with compiling and interpreting RNA analytics and biophysical characterization techniques for RNA such as HPLC, CE, ELISAs, and cell based assays.
• Prior management and mentorship experience; passion for people management and development
• Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities.
• Ex…