Associate 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 of Analytical Development (Oligonucleotides). You will lead analytical development and QC strategy from early clinical stages through commercialization, manage external testing partners, and shape regulatory submissions.

Strong leadership and extensive chromatographic/spectroscopic expertise are essential. The role requires 8+ years in analytical development/quality control, a BS/MS in a related field, and ability to travel

Qualifications

• Minimum of 8 years in Analytical Development and/or Quality Control.
• Bachelor’s or Master’s degree in biology, biochemistry, chemistry, or related field.
• Extensive knowledge of chromatographic and spectroscopic techniques (LC/GC, NMR, Karl Fischer, CD, AEX, chiral separations, RP-HPLC, MS).
• Experience with external vendor management and regulatory submissions.
• Strong communication and project leadership skills.

Responsibilities

• Lead analytical development and QC strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization.
• Serve as the analytical SME for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates.
• Develop, validate, characterize, and transfer methods; establish specifications and release/stability testing.
• Develop, review and approve method transfer/validation protocols.
• Support establishment of critical quality attributes and phase-appropriate specifications.
• Advise on extended characterization of drug substance intermediates.
• Coordinate with QC/QA to oversee cGMP activities and documents.
• Oversee Reference Standard program and coordination of external lab testing.
• Lead CMC analytically focused documentation for biologic INDs/BLAs; support FDA/EMEA interactions.
• Collaborate with partner organizations to meet timelines and address excursions, deviations, and CAPAs.

Skills

Analytical development

Quality control

Method development

Validation

Regulatory submissions

External vendor management

Team collaboration

Travel readiness

Education

Bachelor’s or Master’s degree in biology/biochemistry/chemistry or related field

Tools

LC/GC

NMR

Mass spectrometry

RP-HPLC

Chiral separations

AEX

CD spectroscopy

Job description

Dyne Therapeutics Inc. in Waltham, MA, is seeking an Associate Director of Analytical Development (Oligonucleotides). You will lead analytical development and QC strategy from early clinical stages through commercialization, manage external testing partners, and shape regulatory submissions.

Strong leadership and extensive chromatographic/spectroscopic expertise are essential. The role requires 8+ years in analytical development/quality control, a BS/MS in a related field, and ability to travel