Director, Oligonucleotide Manufacturing
Core
Lead external manufacturing strategy and execution for oligonucleotide payloads from late-stage clinical development through commercial launch.
Role type
Director, Oligonucleotide Manufacturing (Strategy & Operations)
Builds
Clinical and commercial supply of oligonucleotide therapeutics
Domain
Biotechnology / Oligonucleotide Manufacturing
Required skills
Oligonucleotide manufacturing, CMC strategy, CDMO selection and governance, Technology transfer, Scale-up, Process validation, Supply chain planning, Financial stewardship, Cross-functional leadership, Regulatory CMC documentation
Preferred skills
Commercial launch experience, Emerging technology evaluation
Technologies
cGMP, IND, IMPD, BLA
Responsibilities
Translate CMC strategy into integrated manufacturing plans; Select and govern external CDMOs; Ensure uninterrupted supply through capacity planning; Lead technology transfer and scale-up; Prepare CMC sections for regulatory submissions; Advise senior leadership on manufacturing strategy and investment tradeoffs.
Seniority
Director, Strategy & Operations