Associate Director, Oligonucleotide Development
Dyne Therapeutics · Waltham, MA · 6 days ago
On-siteOTHR$159k–$195k/yrFull-time
Primary Responsibilities
- Technical Leadership & Strategy
- Drive Process Excellence
- Define Analytical Strategy
- Innovate & Improve
- Cross-Functional Liaison
- External Partner & Project Management
Physical Presence
Based in Waltham, MA. Physical presence onsite is expected on 4-5 days/week.
Education And Skills Requirements
- PhD or equivalent experience in a scientific discipline
- Minimum of 8+ years related experience
- Proven track record in the process chemistry and development of PMO and ASO oligonucleotides
- Extensive experience defining and implementing CMC strategies from pre-IND/concept phases through clinical cGMP manufacturing
- Direct experience in the selection, qualification, and oversight of CDMOs
- Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.)
- 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
- Strong project management skills, with the ability to independently drive complex CMC programs to completion within aggressive timelines