Director, Biologics Development

The Director, Biologics Development at Dyne Therapeutics is responsible for leading the strategy and execution of biologics development activities to advance the company’s therapeutic programs from early-stage development through clinical and commercial readiness.

About the role

• Drive process excellence by leading the design, optimization, and execution of process development for biologics, ensuring scalability for clinical and commercial supply.
• Innovate and improve by proactively identifying and implementing emerging technologies and continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Define Dyne’s strategy for the implementation of new technologies to lower cost-of-goods by shaping development strategies and aligning with cross-functional teams.
• 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 to function as a liaison with Research and Platform Innovation teams, steering Developability and Manufacturability Assessments, and ensuring a seamless transition into Technical Development.
• Lead the selection, qualification, and strategic management of external CDMOs to ensure alignment with corporate goals and aggressive timelines.
• Spearhead the seamless transfer of biologics processes to external partners, ensuring technical success and data integrity.
• Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions.
• Lead the preparation and technical review of global regulatory filings (IND, IMPD, etc.), ensuring high-quality, submission-ready Module 3 content.
• Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports.
• Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums.

Responsibilities

• 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
    • Shaping development strategies and aligning with cross-functional teams.
• 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, steering Developability and Manufacturability Assessments, and ensuring 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.

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.
• 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.

Pay Range: $190,000 - $230,000 USD. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.