Associate Director, Oligonucleotide Development & CMC

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

Job summary

Dyne Therapeutics is seeking an Associate Director, Oligonucleotide Development to lead the chemical synthesis strategy for PMO and ASO payloads, coordinating with internal teams and external CDMOs to deliver scalable, well-characterized processes, tech transfer, and continuous improvement initiatives across the development lifecycle.

Based in Waltham, MA, this onsite role requires 8+ years in oligonucleotide development, deep CMC expertise, and regulatory authority knowledge (FDA/EMA/ICH) to

Qualifications

• PhD or equivalent experience in a scientific discipline with 8+ years related experience.
• Oligonucleotide Expertise: PMO and ASO synthesis and purification.
• CMC Lifecycle Mastery: defining and implementing CMC strategies from pre-IND through cGMP.
• External Management: oversight of CDMOs including tech transfers.
• Regulatory Authority: knowledge of FDA/EMA/ICH guidelines and Module 3 authoring.
• Analytical Depth: impurity control and physicochemical characterization.
• Strategic Problem Solving: robust risk mitigation and timeline management.
• Collaborative Influence: strong communication to lead cross-functional teams.

Responsibilities

• Lead design, optimization, and execution of process development for PMO/ASO payloads.
• Define analytical strategy focusing on impurity control and materials specs.
• Drive CDMO governance, tech transfer, and external partnerships.
• Prepare and review regulatory submissions (IND/IMPD; Module 3).
• Review development and cGMP documentation, MBRs, and campaign reports.

Skills

Oligonucleotide development

CMC strategy

Regulatory submissions

CDMO management

GMP manufacturing

Analytical development

Cross-functional leadership

Project leadership

Education

PhD or equivalent

Job description

Dyne Therapeutics is seeking an Associate Director, Oligonucleotide Development to lead the chemical synthesis strategy for PMO and ASO payloads, coordinating with internal teams and external CDMOs to deliver scalable, well-characterized processes, tech transfer, and continuous improvement initiatives across the development lifecycle.

Based in Waltham, MA, this onsite role requires 8+ years in oligonucleotide development, deep CMC expertise, and regulatory authority knowledge (FDA/EMA/ICH) to