Senior Director, Process Development, RNA & Small Molecule Therapies
Core
Strategic and operational leader accountable for establishing and delivering robust, scalable, and compliant manufacturing processes for oligonucleotide therapeutics and siRNA modalities from early development through commercialization.
Role type
Senior Director, Process Development (RNA & Small Molecule Therapies)
Builds
Oligonucleotide therapeutics and siRNA modalities for patients with muscle, central nervous system, and cardiac diseases
Domain
Biopharmaceutical manufacturing, RNA therapeutics, GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development strategy, scale-up, GMP manufacturing, tech transfer, regulatory interactions, QbD-aligned control strategies, CMC documentation, CDMO oversight, chemical linking strategies, process characterization
Preferred skills
Platform approach development, cross-functional collaboration, resolving investigations, monitoring performance
Technologies
Oligonucleotide therapeutics, siRNA modalities, GMP facilities
Responsibilities
Define and execute phase-appropriate process development strategies, lead teams covering process development and validation readiness, develop platform approaches to improve efficiency, provide technical oversight for performance monitoring and investigations, support CDMO selection and oversight, drive CMC documentation and regulatory submissions
Seniority
Senior Director, strategic & operational leadership