Biologics Development Leader — CMC Strategy & Tech Transfer

Dyne Therapeutics; Waltham (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA, is seeking a Director, Biologics Development to lead strategy and execution of biologics development from early stage through clinical readiness. This role shapes development plans, drives technical excellence, and partners with cross‑functional teams to advance programs in Duchenne and DM1.

As the core CMC team member, you will shepherd preclinical assets, define strategies for external CDMOs, and contribute to IND/IMPD filings, while delivering scalable,

Qualifications

• Bachelor degree in biology/biochemistry/pharmaceutical sciences or related field.
• 10+ years in biopharmaceutical industry with 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 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 CDMO management, oversight, and technology transfer experience.
• Familiarity with FDA/EMA/ICH guidelines and Module 3 regulatory filings.
• Experience in analytical development including impurity control and viral safety.
• Ability to lead complex programs and influence cross-functional teams and external partners.

Responsibilities

• Drive design, optimization, and execution of biologics process development for scalable clinical and commercial supply.
• Lead Technology Transfer and external CDMO governance to meet aggressive timelines.
• Define and defend phase-appropriate CMC strategies; prepare technical source documents.
• Collaborate with Research and Platform Innovation for candidate nomination and developability assessments.
• Lead regulatory authoring and review of global filings (IND, IMPD); ensure GMP/cGMP documentation.
• Oversee dissemination of technical knowledge through publications and internal/ external presentations.

Skills

Biologics development

CDMO management

CMC strategies

Regulatory filings

Team leadership

Cross-functional collaboration

Education

Bachelor’s degree in Biology/Biochemistry/Pharmaceutical Sciences

Advanced degree preferred

Job description

Dyne Therapeutics in Waltham, MA, is seeking a Director, Biologics Development to lead strategy and execution of biologics development from early stage through clinical readiness. This role shapes development plans, drives technical excellence, and partners with cross‑functional teams to advance programs in Duchenne and DM1.

As the core CMC team member, you will shepherd preclinical assets, define strategies for external CDMOs, and contribute to IND/IMPD filings, while delivering scalable,