Associate Director, Oligonucleotide Development
Core
Lead chemical synthesis strategy for PMO and ASO payload molecules, managing execution internally and across global CDMOs from preclinical through GMP manufacture.
Role type
Associate Director, Oligonucleotide Development (CMC)
Builds
Preclinical assets and GMP drug substances for IND-enabling studies
Domain
Biopharmaceuticals / Oligonucleotide Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process chemistry for PMO/ASO, CMC strategy definition, CDMO selection and management, regulatory Module 3 authoring, analytical development, technology transfer, risk mitigation
Preferred skills
Bioconjugation platform expertise, cross-functional leadership, strategic problem solving
Technologies
PMO synthesis, ASO synthesis, GMP manufacturing, analytical characterization tools
Responsibilities
Design and optimize scalable manufacturing processes for payload molecules; Define analytical strategies for impurity control and physicochemical characterization; Lead selection and qualification of external CDMOs; Author and review global regulatory filings (IND, IMPD) including Module 3 sections; Oversee technology transfer and process characterization documentation
Seniority
Senior, hands-on IC with strategic oversight