Associate Director, Oligonucleotide Drug Substance Manufacturing

Stoke Therapeutics•Bedford, MA

1d•$170,000 - $215,000•Hybrid

About The Position

The Associate Director of Oligonucleotides Manufacturing oversees outsourced cGMP and non-GMP manufacturing activities for clinical candidates and pre-commercial oligonucleotide products. The role requires hands-on experience in cGMP oligonucleotide solid-phase synthesis and purification, support for regulatory filings, and collaboration with the Quality unit to resolve quality events. The position reports to the Director of Oligonucleotide Drug Substance Development and Manufacturing. This role works with contract manufacturing organizations (CMOs), internal CMC and manufacturing teams, Quality, Analytical, and Regulatory CMC to support manufacturing campaigns, troubleshoot issues, develop control strategies, monitor CMO performance, and maintain process and document compliance. The position is hybrid, currently based in Bedford, Massachusetts, and later in Waltham, Massachusetts. Approximately 30% travel is required.

Requirements

PhD and 5+ years of experience supporting GMP ASO manufacturing preferred; alternatively, a Master’s degree and 8+ years of experience, or a Bachelor’s degree in life sciences and 10+ years of progressive responsibility in oligonucleotide synthesis and cGMP manufacturing in pharmaceutical, biotechnology, or a related environment required.
Strong oligonucleotide cGMP manufacturing, PPQ, and oligonucleotide control strategy experience.
Significant hands-on experience in solid-phase synthesis and downstream processing of oligonucleotides.
Experience applying 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.
Strong problem-solving abilities and experience in a regulatory environment.
Familiarity with statistical methods applied to manufacturing controls, such as Design of Experiments (DOE) and Statistical Process Control (SPC).
Ability to work effectively in a fast-paced, dynamic environment with cross-functional teams.

Responsibilities

Oversee cGMP and non-GMP synthetic oligonucleotide manufacturing activities 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 manufacturing campaigns for clinical studies, toxicology materials, and other needs.
Develop and maintain strong relationships with external CMOs to align with company goals and objectives.
Serve as a technical oligonucleotide expert and help resolve manufacturing deviations and CAPAs in collaboration with Quality Assurance.
Monitor and communicate CMO performance against agreed metrics and KPIs, providing feedback and implementing corrective actions as needed.
Support development of oligonucleotide manufacturing control strategies with Analytical, Quality, and Regulatory CMC.
Ensure timely and accurate invoicing and payment processes with CMOs.
Execute change controls, deviations, and other Quality items within the internal QMS.
Interface with the process validation lead on API validation activities and serve as the technical subject matter expert.
Ensure process and document compliance in collaboration with Quality teams.
Support authoring appropriate regulatory filings as required.