Associate Director, Oligonucleotide Drug Substance Manufacturing
Stoke Therapeutics
Associate Director role overseeing outsourced manufacturing of oligonucleotide drug substances for clinical and pre-commercial programs. The position requires hands-on expertise in cGMP synthesis and purification, regulatory filing support, and cross-functional collaboration to resolve manufacturing and quality issues.
Responsibilities
- Oversee cGMP and non-GMP manufacturing activities for oligonucleotides at external CMOs
- Troubleshoot manufacturing issues and investigations using internal and external resources
- Coordinate manufacturing campaign sizing with teams to support clinical studies and preclinical needs
- Interface with Quality unit to resolve quality events in timely manner
- Support authoring regulatory filings as required for submissions
Requirements
- Significant hands-on experience with cGMP oligonucleotide solid-phase synthesis
- Experience with oligonucleotide purification processes and methods
- Knowledge of regulatory requirements for oligonucleotide manufacturing
- Experience managing contract manufacturing organizations (CMOs)
- Ability to author regulatory filings and technical documentation
- Experience troubleshooting manufacturing issues and quality events
Vacancy posted 1 day ago
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