Associate Director, Oligonucleotide Manufacturing (cGMP)

Stoke Therapeutics; Bedford (MA); Hybrid; USD 170,000 - 215,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life, disability insurance

Parental leave

401K with company match

Unlimited vacation time

Tuition assistance

Employee Stock Purchase Program

Job summary

Stoke Therapeutics is seeking an Associate Director of Oligonucleotides Manufacturing to oversee all outsourced manufacturing for clinical candidates and pre-commercial oligonucleotide products. The role reports to the Director of Oligonucleotide Drug Substance Development and Manufacturing and requires strong hands-on cGMP synthesis and purification experience.

Based in Bedford, MA, this hybrid position will partner with Quality and Regulatory groups, support tech transfer and CAPAs, and drive

Qualifications

• A PhD with 5+ years in GMP ASO manufacturing or a related role.

Responsibilities

• Oversee cGMP and non-GMP oligonucleotide manufacturing at CMOs.
• Troubleshoot manufacturing issues with internal and external resources.
• Size manufacturing campaigns to support clinical and toxicology materials.
• Manage relationships with CMOs to align with company goals.
• Serve as technical SME for oligonucleotide manufacturing and CAPAs.
• Monitor CMO performance with KPIs and implement corrective actions.
• Develop control strategies with Analytical, Quality, and Regulatory CMC.
• Ensure timely invoicing and payment processes with CMOs.
• Execute change controls and deviations within the QMS.
• Interface with process validation lead for API validation.

Skills

GMP ASO manufacturing

cGMP oligonucleotide synthesis

CMO management

Regulatory filings support

Quality systems (QMS)

Statistical methods (DOE, SPC)

Problem solving

Cross-functional collaboration

Education

PhD in life sciences

Master's degree in life sciences

Bachelor's degree in life sciences

Tools

CMOs management tools

Analytical instruments for IPC

OC/IPC methods

Job description

Stoke Therapeutics is seeking an Associate Director of Oligonucleotides Manufacturing to oversee all outsourced manufacturing for clinical candidates and pre-commercial oligonucleotide products. The role reports to the Director of Oligonucleotide Drug Substance Development and Manufacturing and requires strong hands-on cGMP synthesis and purification experience.

Based in Bedford, MA, this hybrid position will partner with Quality and Regulatory groups, support tech transfer and CAPAs, and drive