Principal Scientist, Oligonucleotide (PMO, ASO) Development

Dyne Therapeutics • Waltham, MA

13d • Onsite

About The Position

The Principal Scientist of Oligonucleotide Development will lead the chemical synthesis strategy for PMO and modified ASO payload molecules, managing execution both internally and across CDMOs. This role oversees the early development aspects from preclinical process and analytical development leading into GMP manufacture for IND-enabling studies. This role will ensure the delivery of robust, scalable, and cost-effective 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. The Principal Scientist of Oligonucleotide Development will steer the development of preclinical assets and help 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.

Requirements

• Bachelor’s degree in Biochemistry, Chemical Engineering, Chemistry, or Pharmaceutical Sciences
• 8+ years of relevant pharmaceutical/biotech industry experience
• Proven track record in the process chemistry and development of PMO and modified ASO oligonucleotides, including deep technical knowledge of synthesis and purification.
• Experience in Research & Development preferably in a clinical-stage biotechnology company
• Direct experience in the oversight of CDMOs, including managing technology transfers.
• Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.
• Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.
• Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.

Nice To Haves

• advanced degree preferred

Responsibilities

• Lead the design, optimization, and execution of process development for PMO and modified ASO payload molecules, ensuring scalability for clinical supply.
• Support analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both oligonucleotide payloads and conjugated protein drug substances.
• Proactively identify and implement emerging technologies and continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for regulatory submission (IND, IMPD etc.).
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.
• Spearhead the seamless transfer of processes and analytical assays 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.
• Contribute to 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal