Senior Scientist, Process Development - Bioconjugation

Experience in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company.

Familiarity working with oligonucleotides including but not limited to morpholino oligonucleotides, antisense oligonucleotides, and siRNA is desired.

Hands on experience with analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis.

Experience with oversight of external contract development and manufacturing (CDMO)

A strong understanding of biologics and small molecule manufacturing, analytical development, quality control, quality assurance, and regulatory functions.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

The position is responsible for process development, technology transfer, and management of external CDMO activities to ensure development of robust and reliable GMP manufacturing processes for antibody oligonucleotide conjugates and intermediates.

The Senior Scientist will represent CMC Process Sciences as a technical leader and provide guidance to internal process development staff and external vendors on oligonucleotide conjugate development and manufacturing activities from pre-clinical to GMP production for clinical evaluation (Phase 1-3).

This includes active oversight of process establishment, process development, scale-down model verification, and process characterization.

This position works closely with key stakeholders including Platform Research, External Manufacturing, Regulatory Affairs, and Project Management to meet the needs of Dyne’s complex clinical supply chain, supporting our preclinical and clinical programs.

Responsible for drug substance bioconjugation including process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates.

Lead internal CMC Process Development activities via hands-on contribution in the laboratory.