Associate Director, Oligonucleotide Development
Dyne Therapeutics
August 07, 2026
On-site
Waltham, MA
Clinical Research and Development
Role Summary
Associate Director, Oligonucleotide Development will lead the chemical synthesis strategy for PMO and ASO payload molecules, managing execution internally and across global CDMOs through preclinical process/analytical development and GMP manufacture for IND-enabling studies. Primary technical lead for external CDMOs; author/review Module 3 sections for global regulatory filings. Onsite in Waltham, MA (4–5 days/week); not remote.
Primary Responsibilities
Technical Leadership & Strategy
- Lead PMO/ASO process development (design, optimization, execution) for scalable clinical/commercial supply.
- Define analytical strategy: impurity control, raw material specs, physicochemical characterization for payloads and conjugated drug substances.
- Implement continuous improvement/emerging technologies to enhance quality and manufacturing efficiency.
- Act as primary CMC representative; define compliant, phase-appropriate CMC strategies; prepare source documents/publications/oral presentations.
- Prepare/review CMC and product documentation for global regulatory submissions.
- Review/approve development and cGMP documentation (Tech Transfer, Process Characterization, MBRs, Campaign Summary Reports).
External Partner & Project Management
- Select/qualify/manage CDMOs; drive seamless technology transfer and data integrity.
- Resolve complex manufacturing/analytical challenges.
Regulatory & Quality Compliance
- Lead preparation/technical review of IND/IMPD filings; ensure Module 3 quality.
- Review/approve critical cGMP documentation.
- Oversee creation of technical source documents and presentations.
Education and Skills Requirements
- PhD (or equivalent) + 8+ years related experience.
- Deep PMO/ASO process chemistry and synthesis/purification expertise.
- CMC lifecycle experience (pre-IND to clinical cGMP).
- CDMO selection/qualification/oversight; technology transfer and manufacturing campaign management.
- FDA/EMA/ICH knowledge; strong Module 3 authoring/review experience.
- Analytical development expertise (impurities; physicochemical characterization).
- Risk-mitigation problem solving; strong collaboration/communication.
- Project management to deliver complex CMC programs on aggressive timelines.
Pay Range
$159,000–$195,000 USD (base pay).
Associate Director, Oligonucleotide Development will lead the chemical synthesis strategy for PMO and ASO payload molecules, managing execution internally and across global CDMOs through preclinical process/analytical development and GMP manufacture for IND-enabling studies. Primary technical lead for external CDMOs; author/review Module 3 sections for global regulatory filings. Onsite in Waltham, MA (4–5 days/week); not remote.
Primary Responsibilities
Technical Leadership & Strategy
- Lead PMO/ASO process development (design, optimization, execution) for scalable clinical/commercial supply.
- Define analytical strategy: impurity control, raw material specs, physicochemical characterization for payloads and conjugated drug substances.
- Implement continuous improvement/emerging technologies to enhance quality and manufacturing efficiency.
- Act as primary CMC representative; define compliant, phase-appropriate CMC strategies; prepare source documents/publications/oral presentations.
- Prepare/review CMC and product documentation for global regulatory submissions.
- Review/approve development and cGMP documentation (Tech Transfer, Process Characterization, MBRs, Campaign Summary Reports).
External Partner & Project Management
- Select/qualify/manage CDMOs; drive seamless technology transfer and data integrity.
- Resolve complex manufacturing/analytical challenges.
Regulatory & Quality Compliance
- Lead preparation/technical review of IND/IMPD filings; ensure Module 3 quality.
- Review/approve critical cGMP documentation.
- Oversee creation of technical source documents and presentations.
Education and Skills Requirements
- PhD (or equivalent) + 8+ years related experience.
- Deep PMO/ASO process chemistry and synthesis/purification expertise.
- CMC lifecycle experience (pre-IND to clinical cGMP).
- CDMO selection/qualification/oversight; technology transfer and manufacturing campaign management.
- FDA/EMA/ICH knowledge; strong Module 3 authoring/review experience.
- Analytical development expertise (impurities; physicochemical characterization).
- Risk-mitigation problem solving; strong collaboration/communication.
- Project management to deliver complex CMC programs on aggressive timelines.
Pay Range
$159,000–$195,000 USD (base pay).