Oligonucleotide Development Lead - CMC & CDMO Strategy

BioSpace; Waltham (MA); On-site; USD 159,000 - 195,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA, seeks an Associate Director of Oligonucleotide Development to lead PMO and ASO process chemistry, analytical strategy, and external partnerships for IND-enabling programs.

The role requires 8+ years in oligonucleotide development, strong regulatory experience, and a proven ability to drive translational manufacturing strategies in a matrixed environment.

Qualifications

• PhD or equivalent in a scientific discipline with 8+ years related experience.
• Proven track record in oligonucleotide process chemistry and development (PMO/ASO).
• Regulatory experience with FDA/EMA/ICH; Module 3 preparation.
• External CDMO management including technology transfers and cGMP manufacturing.
• Strong cross-functional leadership and communication skills.

Responsibilities

• Lead the design, optimization, and execution of PMO/ASO process development for clinical and commercial supply.
• Set vision for analytical development, impurity control, and physicochemical characterization for payloads and conjugates.
• Spearhead external CDMO governance, tech transfer, and data integrity.
• Lead regulatory authoring and review for global submissions (IND, IMPD; Module 3).
• Oversee development documentation: tech transfers, MBRS, and campaign summaries.
• Mentor teams and influence cross-functional partners to meet aggressive timelines.

Skills

Oligonucleotide Expertise

CMC Lifecycle Mastery

External Management

Regulatory Authority

Analytical Depth

Strategic Problem Solving

Collaborative Influence

Project Leadership

Education

PhD or equivalent experience

Job description

Dyne Therapeutics in Waltham, MA, seeks an Associate Director of Oligonucleotide Development to lead PMO and ASO process chemistry, analytical strategy, and external partnerships for IND-enabling programs.

The role requires 8+ years in oligonucleotide development, strong regulatory experience, and a proven ability to drive translational manufacturing strategies in a matrixed environment.