Senior Director, Drug Substance Manufacturing
Dyne Therapeutics(1 month ago)
About this role
Senior Director, Drug Substance Manufacturing at Dyne Therapeutics leads the organization’s strategy for drug substance (Fab-oligonucleotide conjugates) development and CMC capabilities to support clinical programs and commercialization. The role partners cross-functionally with Development, R&D, Clinical, Regulatory Affairs, Project Management, and executive leadership and coordinates external manufacturing and testing partners. The position is based in Waltham, MA and supports building scalable clinical supply chain and regulatory readiness.
Required Skills
- Bioconjugation
- Process Scale-Up
- PPQ
- GMP Compliance
- Vendor Management
- CDMO Management
- Supplier Oversight
- Inventory Control
- Logistics
- Tech Transfer
+10 more
Qualifications
- Bachelor's Degree in Biology, Biochemistry, or Chemistry
- Advanced Degree Preferred
About Dyne Therapeutics
dyne-tx.comDyne Therapeutics is a biotechnology company developing nucleic acid–based therapies for rare, inherited muscle diseases. With the mission "Repairing muscle, reclaiming now," it aims to create life‑transforming medicines that restore muscle function and improve patients' lives. Dyne advances programs from discovery into clinical development with a focus on genetic muscle disorders (including various muscular dystrophies) and works with partners to accelerate delivery of therapies to patients.
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