This role is responsible for leading external drug product manufacturing activities for small molecule and oligonucleotide products in a cGMP environment
Job Summary
This role is responsible for leading external drug product manufacturing activities for small molecule and oligonucleotide products in a cGMP environment.
The position requires managing CMO relationships including selection, onboarding, and performance while ensuring reliable clinical and commercial supply.
Candidates must have demonstrated expertise in CMC development and the ability to author or review sections for global regulatory filings such as INDs, NDAs, and MAAs.
Matching Summary
This role is responsible for leading external drug product manufacturing activities for small molecule and oligonucleotide products in a cGMP environment.
Skills & Requirements
Must-have
Small molecule drug product manufacturing
Oligonucleotide formulation experience
CMC regulatory filing authoring
cGMP environment leadership
CMO relationship management
Nice-to-have
Multiple dosage forms expertise
Cross-functional collaboration skills
Continuous improvement initiatives
Global organization experience
Key Requirements
PhD or equivalent relevant experience
10-15+ years pharmaceutical manufacturing experience
Expertise in small molecule drug product development