Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .
Role Summary
The Associate Director, Oligonucleotide Development leads chemical synthesis and development strategies for PMO and modified ASO payload molecules, overseeing execution internally and through external CDMOs. This role provides technical leadership across preclinical process and analytical development through technology transfer and GMP manufacturing for IND-enabling studies.
The Associate Director ensures the development of robust, scalable, and cost-effective manufacturing processes and serves as a key technical lead with external manufacturing partners. The role contributes to CMC strategy for preclinical and clinical-stage programs and supports global regulatory filings, including authoring and reviewing relevant Module 3 content.
This role is based in Waltham, MA and is not eligible for remote work. Physical presence onsite is expected 5 days per week.
Primary Responsibilities include:
Oligonucleotide Process & Analytical Development
Lead process development, optimization, and scale-up strategies for PMO and modified ASO payload molecules to support preclinical and clinical supply.
Provide technical leadership for oligonucleotide synthesis, purification, characterization, and associated manufacturing processes.
Support analytical development strategies, including impurity control, raw material specifications, and physicochemical characterization of oligonucleotide payloads and conjugated drug substances.
Identify and implement technologies and process improvements that enhance product quality, scalability, manufacturing robustness, and efficiency.
Prepare technical source documents, scientific presentations, and other development documentation.
External Manufacturing & Technology Transfer
Serve as a key technical lead for CDMOs responsible for oligonucleotide process development and manufacturing.
Lead technology transfer of manufacturing processes and analytical methods to external partners, ensuring effective execution, knowledge transfer, and data integrity.
Provide technical oversight of external development and manufacturing activities to ensure alignment with program timelines, quality expectations, and CMC objectives.
Lead investigation and resolution of complex process, manufacturing, and analytical challenges using scientifically rigorous and data-driven approaches.
CMC, Regulatory & GMP Execution
Contribute to CMC strategies supporting the advancement of preclinical and clinical-stage programs.
Author and review relevant CMC and product-related documentation for global regulatory submissions, including INDs and IMPDs.
Review and approve development and cGMP documentation, including technology transfer protocols, process characterization documents, Master Batch Records, and campaign summary reports.
Partner cross-functionally with Analytical Development, Quality, Regulatory, Manufacturing, and other CMC functions to ensure development and manufacturing activities support program objectives.
Experience and Skills Requirements:
Bachelor’s degree in Biochemistry, Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
8+ years of relevant pharmaceutical or biotechnology industry experience, or an equivalent combination of education and…