Senior Scientist, Process Development - Bioconjugation

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Responsibilities

• Lead drug substance bioconjugation including process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates.
• Manage external CDMO activities, including process development, optimization, and technology transfer.
• Provide hands-on contribution to internal CMC Process Development activities in the laboratory.
• Partner with Research to support bioconjugation development and enhance tech transfer processes.
• Represent bioconjugation Drug Substance process as a technical leader in cross-functional CMC teams.
• Review and approve documents related to development and cGMP operations, including Master Batch Records (MBRs) and Campaign Summary Reports.
• Prepare technical source documents and CMC documentation for global regulatory submissions.

Requirements

• PhD or equivalent experience in a scientific discipline
• Minimum 5+ years of experience working with bioconjugates
• Deep understanding of conjugation chemistries, preparative chromatography, and TFF
• Experience in biopharmaceutical CMC management or R&D
• Hands-on experience with analytical techniques including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis
• Experience with oversight of external CDMOs
• Strong understanding of biologics and small molecule manufacturing, analytical development, and regulatory functions

Preferred Qualifications

• Familiarity with oligonucleotides (morpholino, antisense, or siRNA)
• Experience in a clinical-stage biotechnology company