Director, Analytical Development – Oligonucleotides

Dyne Therapeutics, Inc.; Waltham (MA); On-site; USD 160,000 - 200,000; Full time

Job summary

Dyne Therapeutics, Inc. in Waltham, MA, is seeking an Associate Director, Analytical Development to lead analytical development and QC strategies for oligonucleotide and small-molecule intermediates across clinical development through commercialization.

This role partners with CMC, Quality, Regulatory Affairs, and external labs, providing strategic leadership and oversight of analytical programs. The position requires at least 8 years in analytical development/QA, advanced degree in biology or

Qualifications

• Minimum 8 years in Analytical Development and/or Quality Control.
• Degree in biology, biochemistry, chemistry or related field.
• Experience with cGMP and regulatory expectations.
• Knowledge of analytical techniques including LC/GC, NMR, Karl Fischer, CD, AEX, chiral separations, RP-HPLC and MS.

Responsibilities

• Lead analytical development and QC strategies from early clinical development through commercialization.
• Serve as analytical SME for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates.
• Responsibilities include method development, validation, transfer, specifications, release and stability testing.
• Develop and implement QC strategy for small molecules and oligonucleotides per ICH framework.
• Oversee cGMP documents, change controls, deviations, CAPAs, batch release support, and stability programs.

Skills

Analytical Development

Quality Control

Regulatory Submissions

Team Collaboration

Education

Bachelor’s or Master’s in Biology/Chemistry/Biochemistry

Tools

LC/LC-MS

NMR

Karl Fischer

RP-HPLC

Chiral separations

CD

Job description

Dyne Therapeutics, Inc. in Waltham, MA, is seeking an Associate Director, Analytical Development to lead analytical development and QC strategies for oligonucleotide and small-molecule intermediates across clinical development through commercialization.

This role partners with CMC, Quality, Regulatory Affairs, and external labs, providing strategic leadership and oversight of analytical programs. The position requires at least 8 years in analytical development/QA, advanced degree in biology or