Associate Director, Oligonucleotide Development

Dyne Therapeutics•Waltham, MA

2d•$159,000 - $200,000•Onsite

About The Position

The Associate Director, Oligonucleotide Development leads chemical synthesis and development strategies for PMO and modified ASO payload molecules, overseeing work internally and through external CDMOs. The role provides technical leadership across preclinical process and analytical development, technology transfer, and GMP manufacturing for IND-enabling studies. The position is responsible for developing robust, scalable, and cost-effective manufacturing processes and serving as a technical lead with external manufacturing partners. It contributes to CMC strategy for preclinical and clinical-stage programs and supports global regulatory filings, including authoring and reviewing relevant Module 3 content. The role is based onsite in Waltham, Massachusetts, five days per week, and is not eligible for remote work.

Requirements

Bachelor’s degree in Biochemistry, Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
At least 8 years of relevant pharmaceutical or biotechnology industry experience, or an equivalent combination of education and experience.
Demonstrated expertise in process chemistry and development of PMO and/or modified ASO oligonucleotides, including synthesis, purification, and scale-up.
Experience supporting pharmaceutical development programs.
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, including 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.

Nice To Haves

Advanced degree in Biochemistry, Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
Experience supporting pharmaceutical development programs within a clinical-stage biotechnology or pharmaceutical organization.

Responsibilities

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 to 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, data-driven approaches.
Contribute to CMC strategies supporting 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.