Associate Director, Oligonucleotide Development

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.

• 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.

• 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.

• 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.

• 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 experience.
• Demonstrated expertise in the process chemistry and development of PMO and/or modified ASO oligonucleotides, including synthesis, purification, and scale-up.
• Experience supporting pharmaceutical development programs, preferably within a clinical-stage biotechnology or pharmaceutical organization.
• Demonstrated experience providing technical oversight of CDMOs and leading technology transfer activities.
• Strong understanding of analytical development principles, including impurity control strategies, raw material specifications, and physicochemical characterization.
• Experience contributing to CMC regulatory submissions, including INDs, IMPDs, or comparable global filings.
• Working knowledge of cGMP requirements and development-stage manufacturing documentation.
• Strong scientific judgment and problem-solving skills with the ability to assess technical risk, establish priorities, and drive solutions in a rapidly evolving development environment.
• Demonstrated ability to influence and collaborate effectively across cross-functional teams and with external partners.

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.