Associate Director, Drug Product Manufacturing

Responsibilities

• Lead clinical and commercial drug product manufacturing activities for large molecule, sterile injectable programs
• Serve as the primary technical owner for drug product manufacturing at CDMOs
• Drive day-to-day manufacturing activities, including preparation and review of batch records and process documentation
• Maintain on-site presence at CDMOs during manufacturing campaigns to ensure execution quality
• Oversee batch disposition activities in collaboration with Quality Assurance
• Lead investigation and resolution of manufacturing deviations, process failures, and yield issues
• Author and review deviation reports, investigations, CAPAs, and change controls
• Drive tech transfer activities for internal and external manufacturing partners
• Partner with internal and external teams on process development and characterization to support regulatory submissions

Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• 8+ years of experience with a BS or 3+ years with an MS in drug product manufacturing
• Experience in parenteral drug product manufacturing with CDMO oversight
• Strong knowledge of sterile manufacturing and fill-finish operations
• Experience with batch records, deviations, and tech transfer
• Deep understanding of cGMP and regulatory expectations (FDA, EMA)

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, targeting muscle and the central nervous system (CNS) to address the root cause of disease.