Associate Director, Oligonucleotide Development

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 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.

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Pay and benefits

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.