Director, Biologics Development

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 and follow us onXLinkedInandFacebook.

Role Summary:

The Director Biologics Development leads the strategy and execution of biologics development activities to advance Dynes 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 Dynes 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.

Primary 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 Dynes 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.

Regulatory & Quality Compliance

• 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.

Education and Skills Requirements:

• Bachelors 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

#LI-Onsite

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.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age color disability gender national origin race religion sexual orientation veteran status or any classification protected by federal state or local law.