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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. com/ , and follow us on X , LinkedIn and Facebook . Role Summary: The Director, Biologics Development leads the strategy and execution of biologics development activities to advance Dyne’s therapeutic programs from early-stage development through clinical and commercial readiness.

This role shapes development strategies, ensures alignment across cross-functional teams, and drives technical excellence in biologics development. The Director applies deep scientific and industry expertise to solve complex challenges, influence decision-making, and enable successful program delivery that supports Dyne’s mission of delivering meaningful outcomes for patients. The role will ensure the delivery of robust, scalable, and cost-effective second-generation manufacturing processes, serve as the primary technical lead for external CDMOs, driving aggressive timelines while delivering well-characterized products optimized for our proprietary bioconjugation platform.

As a core CMC team member, the Director of Biologics Development will steer the development of preclinical assets and define CMC strategies within a matrixed environment. ) by authoring and reviewing key Module 3 sections. This role is based in Waltham, MA and requires regular onsite presence, typically four to five days per week.

Responsibilities

Include: Technical Leadership & Strategy Drive Process Excellence: Lead the design, optimization, and execution of process development for biologics, ensuring scalability for clinical and commercial supply. Innovate & Improve: Proactively identify and implement emerging technologies and continuous improvement initiatives to enhance product quality and manufacturing efficiency. Define Dyne’s strategy for implementation of new technologies to lower cost-of-goods Cross-Functional Liaison: Act as the primary CMC representative for Technical Development to internal teams, defining and defending compliant, phase-appropriate CMC strategies in a matrixed environment.

Prepare technical source documents, publications, and oral presentations Function as liaison with Research and Platform Innovation teams, to prepare new biologics assets for Candidate Nomination, steer Developability and Manufacturability Assessments, and ensure a seamless transition into Technical Development External Partner & Project Management CDMO Governance: Lead the selection, qualification, and strategic management of external CDMOs to ensure alignment with corporate goals and aggressive timelines. Technology Transfer: Spearhead the seamless transfer of biologics processes to external partners, ensuring technical success and data integrity. Issue Resolution: Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions.

), ensuring high-quality, submission-ready Module 3 content. GMP Oversight: Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports.