Director, Biologics Development

Dyne Therapeutics•Waltham, MA

3d•Onsite

About The Position

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. 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. The role will play a critical role in global regulatory filings (IND, IMPD, etc.) 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.

Requirements

Bachelor’s degree in Biology, Biochemistry, Pharmaceutical Sciences, or related discipline; advanced degree preferred
10+ years of biopharmaceutical industry experience with demonstrated progression in biologics development
Experience leading teams or cross-functional initiatives in a matrixed environment
Proven track record advancing biologics programs from early development through clinical cGMP manufacturing
Deep expertise in protein expression, purification, and biologics process development
Experience defining and executing CMC strategies from pre-IND through clinical development
Strong track record managing CDMOs, including oversight and technology transfer
Working knowledge of FDA, EMA, and ICH guidelines, with experience contributing to Module 3 regulatory filings
Experience in analytical development, including impurity control, viral safety, and physicochemical characterization
Demonstrated ability to lead complex programs and influence cross-functional teams and external partners
Strong strategic thinking, problem-solving, and decision-making skills in a fast-paced environment
Excellent communication skills, with the ability to clearly convey complex technical concepts
Effective project management capabilities, balancing competing priorities and timelines

Responsibilities

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
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.
Regulatory Authoring: Lead the preparation and technical review of global regulatory filings (IND, IMPD, etc.), 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.
Knowledge Dissemination: Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums.