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Associate Director, Oligonucleotide Drug Substance Manufacturing
Stoke Therapeutics. Oversee cGMP and non-GMP manufacturing activities for synthetic oligonucleotides at Contract Manufacturing Organizations (CMOs) .
Posted 10/27/2026full-timeBedford • Massachusetts • United StatesSenior💰 $170,000 - $215,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in oligonucleotide cGMP manufacturing, including solid-phase synthesis and downstream processing, while effectively managing relationships with CMOs and ensuring compliance with quality standards and regulatory requirements.
Highest-signal resume keywords
Oligonucleotide CGMP ManufacturingSolid-Phase SynthesisChange Control ManagementTechnical Transfer DocumentationStatistical Process Control
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Oligonucleotide SynthesisDownstream ProcessingAnalytical Methods ApplicationProcess ValidationQuality Management System (QMS)Risk AssessmentCAPA PlansDesign of Experiments (DOE)In-Process Control (IPC)Oligo Control Strategy
Soft Skills
Cross-Functional CollaborationProblem SolvingEffective CommunicationRelationship ManagementAdaptability
Industry Keywords
CGMPContract Manufacturing Organizations (CMOs)Clinical StudiesPharmaceuticalBiotechnologyRegulatory EnvironmentQuality AssurancePerformance MetricsCorrective ActionsManufacturing Deviations
About the role
Key responsibilities & impact- Oversee cGMP and non-GMP manufacturing activities for synthetic oligonucleotides at Contract Manufacturing Organizations (CMOs)
- Troubleshoot manufacturing issues and investigations using internal and external resources
- Work with CMC, manufacturing, and other functional areas to size campaigns supporting clinical studies, toxicology materials, and other needs
- Develop and maintain relationships with external CMOs
- Serve as technical oligonucleotide expert and resolve manufacturing deviations and CAPAs with Quality Assurance
- Monitor and communicate CMO performance against metrics and KPIs; provide feedback and implement corrective actions
- Support development of oligonucleotide manufacturing control strategies with Analytical, Quality, and Regulatory CMC
- Ensure accurate CMO invoicing and payment processes
- Execute change controls, deviations, and other Quality items within the internal QMS
- Interface with the process validation lead on API validation activities as technical SME
- Ensure process and document compliance with Quality teams
- Report to the Director of Oligonucleotide Drug Substance Development and Manufacturing
Requirements
What you’ll need- Bachelor’s degree in life sciences with 10+ years of progressive responsibility in oligonucleotide synthesis and cGMP manufacturing in pharmaceutical, biotechnology, or a related environment required; alternatively, Master’s and 8+ years, or PhD and 5+ years of experience supporting GMP ASO manufacturing preferred
- Strong oligonucleotide cGMP manufacturing, PPQ, and oligo control strategy experience
- Significant hands-on experience in solid-phase synthesis and downstream processing of oligonucleotides
- Application of modern analytical methods to in-process control (IPC) of manufacturing activities
- Proven experience managing and working with CMDOs and CROs
- Deep knowledge of cGMP requirements related to manufacturing activities
- Experience authoring tech transfer documents, change controls, risk assessments, CAPA plans, and other quality documents
- Experience with a regulatory environment
- Familiarity with statistical methods including Design of Experiments (DOE) and Statistical Process Control (SPC)
- Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams
- Approximately 30% travel required
Benefits
Comp & perks- Annual bonus
- Equity participation
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Long-term disability insurance
- Short-term disability insurance
- Paid parental leave
- 401K plan with company match
- Unlimited vacation time
- Tuition assistance
- Employee Stock Purchase Program (ESPP)
- Flexible work arrangements
- Diversity, Inclusion, and Belonging (DIB) initiatives