Director, Chemical (drug Substance) Manufacturing Management
Ultragenyx
Brisbane, CA, United States
On-site
Cgmp manufacturing environment
Small molecule and oligonucleotide synthesis
Cmo management and governance
The role provides technical and operational leadership for drug substance manufacturing activities supporting small molecule and oligonucleotide programs
Job Summary
The role provides technical and operational leadership for drug substance manufacturing activities supporting small molecule and oligonucleotide programs.
Candidates will manage external CMO relationships including selection, onboarding, and performance governance to ensure reliable clinical and commercial supply.
The position requires leading CMC projects and authoring sections for global regulatory filings such as INDs, IMPDs, NDAs, and MAAs.
Matching Summary
The role provides technical and operational leadership for drug substance manufacturing activities supporting small molecule and oligonucleotide programs.
Skills & Requirements
Must-have
cGMP manufacturing environment
small molecule and oligonucleotide synthesis
CMO management and governance
process development and optimization
regulatory filing support (IND, NDA)
cross-functional CMC team leadership
Nice-to-have
rare disease medicine experience
rapid development approach knowledge
collaborative ecosystem building
continuous improvement mindset
Key Requirements
Ph.D. in chemistry or chemical engineering
8-12 years pharmaceutical/biopharma experience
Progressive responsibility in CMC and manufacturing