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, Analytical Development, Oligonucleotides leads analytical development and supports quality control strategies for oligonucleotide and small-molecule intermediates across clinical development, registration, and commercialization. This role provides strategic and technical leadership for analytical method development, validation, technology transfer, specifications, release testing, stability programs, impurity control, and product characterization.
The Associate Director independently leads multiple analytical workstreams and makes decisions that influence program strategy, product quality, regulatory submissions, and clinical supply. The role provides oversight of CDMOs, contract testing laboratories, and other external partners to ensure analytical activities meet scientific, regulatory, quality, timeline, and business requirements.
Working closely with CMC, Quality, Regulatory Affairs, Supply Chain, Research and Development, Clinical, and Project Management, this position establishes analytical priorities, resolves complex technical issues, manages program risks, and guides cross-functional decision-making. The Associate Director also serves as an analytical subject matter expert, mentors colleagues, and strengthens analytical capabilities and practices across the organization.
This is a full-time position based in Waltham, MA without the possibility of being remote. Physical presence onsite is expected on 4-5 days/week.
Primary Responsibilities Include:
Lead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization
Serve as the analytical SME and strategic lead for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates
Responsibilities will include aspects of analytical development of drug substance intermediates including method development, validation, characterization, tech transfer, specifications, release, and stability testing
Assist with developing the analytical/QC strategy for small molecules and oligonucleotides guided by ICH framework
Develop, review, and approve method transfer/validation protocols and validation approaches
Support establishment of critical quality attributes and phase-appropriate specifications
Advise and plan extended characterization of drug substance intermediates to expand product understanding
Partner with QC and QA to provide oversight of cGMP activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.)
Oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate
Lead, author, approve, or provide strategic direction for CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions
Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated,…