Lead Scientist, Oligonucleotide PMO/ASO Development

Dyne Tx; Waltham, Northern (MA, KY); Hybrid; USD 159,000 - 200,000; Full time

Job summary

Dyne Therapeutics is seeking a Principal Scientist for Oligonucleotide Development in Waltham, MA. Lead PMO and modified ASO process development, coordinate with CDMOs, and drive regulatory submissions under an on-site model.

You will shape preclinical-to-GMP processes, manage analytical strategies, and contribute to IND/IMPD assets while guiding cross-functional teams in a fast-paced biotech setting.

Qualifications

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Responsibilities

• Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and modified ASO payload molecules, ensuring scalability for clinical supply.
• Define Analytical Strategy: 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.
• Innovate & Improve: 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
• Technology Transfer:Spearhead the seamless transfer of processes and analytical assays 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 Authoring:Contribute to 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.

Skills

Oligonucleotide development

Process chemistry

CDMO management

Education

Bachelor's degree in Biochemistry, Chemical Engineering, Chemistry, or Pharmaceutical Sciences

8+ years industry experience

Job description

Dyne Therapeutics is seeking a Principal Scientist for Oligonucleotide Development in Waltham, MA. Lead PMO and modified ASO process development, coordinate with CDMOs, and drive regulatory submissions under an on-site model.

You will shape preclinical-to-GMP processes, manage analytical strategies, and contribute to IND/IMPD assets while guiding cross-functional teams in a fast-paced biotech setting.